title: Validation (drug manufacture)

abstract:
The process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages. In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results. The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following:
  - Equipment validation
  - Facilities validation
  - HVAC system validation
  - Cleaning validation
  - Process Validation
  - Analytical method validation
  - Computer system validation Similarly, the activity of qualifying systems and equipment is divided into a number of subsections including the following:
  - Design qualification (DQ)
  - Component qualification (CQ)
  - Installation qualification (IQ)
  - Operational qualification (OQ)
  - Performance qualification (PQ)

text:
# Validation (drug manufacture)

The process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages. In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results. The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following:

Similarly, the activity of qualifying systems and equipment is divided into a number of subsections including the following:

* Design qualification (DQ)
* Component qualification (CQ)
* Installation qualification (IQ)
* Operational qualification (OQ)
* Performance qualification (PQ)

## History

The concept of validation was first proposed by two Food and Drug Administration (FDA) officials, Ted Byers and Bud Loftus, in 1979 in USA, to improve the quality of pharmaceuticals. It was proposed in direct response to several problems in the sterility of large volume parenteral market. The first validation activities were focused on the processes involved in making these products, but quickly spread to associated processes including environmental control, media fill, equipment sanitization and purified water production.

The concept of validation was first developed for equipment and processes and derived from the engineering practices used in delivery of large pieces of equipment that would be manufactured, tested, delivered and accepted according to a contract The use of validation spread to other areas of industry after several large-scale problems highlighted the potential risks in the design of products. The most notable is the Therac-25 incident. Here, the software for a large radiotherapy device was poorly designed and tested. In use, several interconnected problems led to several devices giving doses of radiation several thousands of times higher than intended, which resulted in the death of three patients and several more being permanently injured.

In 2005 an individual wrote a standard by which the transportation process could be validated for cold chain products. This standard was written for a biological manufacturing company and was then written into the PDA's Technical Report # 39,thus establishing the industry standard for cold chain validation. This was critical for the industry due to the sensitivity of drug substances, biologics and vaccines to various temperature conditions. The FDA has also been very focused on this final area of distribution and the potential for a drug substances quality to be impacted by extreme temperature exposure. 4.6. Accuracy: Accuracy of an analytical procedure is the closeness of test results obtained by that procedure to the true value. The accuracy of an analytical procedure shall be established across its range. 4.7. Precision: The precision of an analytical procedure expresses the closeness of agreement between a series of measurements obtained from multiple sampling of the same homogeneous sample under the prescribed conditions. 4.8. Method precision (Repeatability): Method precision carried out on different test preparation of a homogenous sample within short interval of time under same experimental conditions. 4.9. Intermediate precision (Ruggedness): Intermediate precision (Ruggedness) expresses within-laboratories variations i.e. different days, different analysts, different equipment etc. 4.10. Range: The range of an analytical procedure is the interval between the upper and lower concentration of analyte in the sample for which it has been demonstrated that the analytical procedure has a suitable level of precision, accuracy and linearity

## Reasons for validation

FDA, or any other food and drugs regulatory agency around the globe not only ask for a product that meets its specification but also require a process, procedures, intermediate stages of inspections, and testing adopted during manufacturing are designed such that when they are adopted they produce consistently similar, reproducible, desired results which meet the quality standard of product being manufactured and complies the Regulatory and Security Aspects. Such procedures are developed through the process of validation. This is to maintain and assure a higher degree of quality of food and drug products. *"Process validation is defined as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. Process validation involves a series of activities taking place over the lifecycle of the product and process."*. A properly designed system will provide a high degree of assurance that every step, process, and change has been properly evaluated before its implementation. Testing a sample of a final product is not considered sufficient evidence that every product within a batch meets the required specification.

## Validation Master Plan

The Validation Master Plan is a document that describes how and when the validation program will be executed in a facility. Even though it is not mandatory, it is the document that outlines the principles involved in the qualification of a facility, defines the areas and systems to be validated and provides a written program for achieving and maintaining a qualified facility with validated processes. It is the foundation for the validation program and should include process validation, facility and utility qualification and validation, equipment qualification, cleaning and computer validation. The regulations also set out an expectation that the different parts of the production process are well defined and controlled, such that the results of that production will not substantially change over time.

## The validation process

The validation scope, boundaries and responsibilities for each process or groups of similar processes or similar equipment's must be documented and approved in a validation plan. These documents, terms and references for the protocol authors are for use in setting the scope of their protocols. It must be based on a Validation Risk Assessment (VRA) to ensure that the scope of validation being authorised is appropriate for the complexity and importance of the equipment or process under validation. Within the references given in the VP the protocol authors must ensure that all aspects of the process or equipment under qualification; that may affect the efficacy, quality and or records of the product are properly qualified. Qualification includes the following steps:

* Design qualification (DQ)- Demonstrates that the proposed design (or the existing design for an off-the-shelf item) will satisfy all the requirements that are defined and detailed in the User Requirements Specification (URS). Satisfactory execution of the DQ is a mandatory requirement before construction (or procurement) of the new design can be authorised.
* Installation qualification (IQ) – Demonstrates that the process or equipment meets all specifications, is installed correctly, and all required components and documentation needed for continued operation are installed and in place.
* Operational qualification (OQ) – Demonstrates that all facets of the process or equipment are operating correctly.
* Performance qualification (PQ) – Demonstrates that the process or equipment performs as intended in a consistent manner over time.
* Component qualification (CQ) – is a relatively new term developed in 2005. This term refers to the manufacturing of auxiliary components to ensure that they are manufactured to the correct design criteria. This could include packaging components such as folding cartons, shipping cases, labels or even phase change material. All of these components must have some type of random inspection to ensure that the third party manufacturer's process is consistently producing components that are used in the world of GMP at drug or biologic manufacturer.

There are instances when it is more expedient and efficient to transfer some tests or inspections from the IQ to the OQ, or from the OQ to the PQ. This is allowed for in the regulations, provided that a clear and approved justification is documented in the Validation Plan (VP).

This combined testing of OQ and PQ phases is sanctioned by the European Commission Enterprise Directorate-General within ‘Annex 15 to the EU Guide to Good Manufacturing Practice guide’ (2001, p. 6) which states that:

> "*Although PQ is described as a separate activity, it may in some cases be appropriate to perform it in conjunction with OQ.*"

## Computer System Validation

This requirement has naturally expanded to encompass computer systems used both in the development and production of, and as a part of pharmaceutical products, medical devices, food, blood establishments, tissue establishments, and clinical trials. In 1983 the FDA published a guide to the inspection of Computerized Systems in Pharmaceutical Processing, also known as the 'bluebook'. Recently both the American FDA and the UK Medicines and Healthcare products Regulatory Agency have added sections to the regulations specifically for the use of computer systems. In the UK, computer validation is covered in Annex 11 of the EU GMP regulations (EMEA 2011). The FDA introduced 21 CFR Part 11 for rules on the use of electronic records, electronic signatures (FDA 1997). The FDA regulation is harmonized with ISO 8402:1994, which treats "verification" and "validation" as separate and distinct terms. On the other hand, many software engineering journal articles and textbooks use the terms "verification" and "validation" interchangeably, or in some cases refer to software "verification, validation, and testing (VV&T)" as if it is a single concept, with no distinction among the three terms. The General Principles of Software Validation (FDA 2002) defines verification as *"Software verification provides objective evidence that the design outputs of a particular phase of the software development life cycle meet all of the specified requirements for that phase."* It also defines Validation as *"Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled"*. The software validation guideline states: “The software development process should be sufficiently well planned, controlled, and documented to detect and correct unexpected results from software changes." Annex 11 states "The validation documentation and reports should cover the relevant steps of the life cycle."

Weichel (2004) recently found that over twenty warning letters issued by the FDA to pharmaceutical companies specifically cited problems in Computer System Validation between 1997 and 2001.

Probably the best known industry guidance available is the GAMP Guide, now in its fifth edition and known as GAMP5 published by ISPE (2008). This guidance gives practical advice on how to satisfy regulatory requirements.

### Scope of Computer Validation

The definition of validation above discusses production of evidence that a system will meet its specification. This definition does not refer to a computer application or a computer system but to a process. The main implications in this are that validation should cover all aspects of the process including the application, any hardware that the application uses, any interfaces to other systems, the users, training and documentation as well as the management of the system and the validation itself after the system is put into use. The PIC/S guideline (PIC/S 2004) defines this as a 'computer related system'. Much effort is expended within the industry upon validation activities, and several journals are dedicated to both the process and methodology around validation, and the science behind it.

### Risk Based Approach To Computer Validation

In the recent years, a risk-based approach has been adopted within the industry, where the testing of computer systems (emphasis on finding problems) is wide-ranging and documented but not heavily evidenced (i.e. hundreds of screen prints are not gathered during testing). Annex 11 states "Risk management should be applied throughout the lifecycle of the computerised system taking into account patient safety, data integrity and product quality. As part of a risk management system, decisions on the extent of validation and data integrity controls should be based on a justified and documented risk assessment of the computerised system."

The subsequent validation or verification of computer systems targets only the "GxP critical" requirements of computer systems. Evidence (e.g. screen prints) is gathered to document the validation exercise. In this way it is assured that systems are thoroughly tested, and that validation and documentation of the "GxP critical" aspects is performed in a risk-based manner, optimizing effort and ensuring that computer system's fitness for purpose is demonstrated.

The overall risk posed by a computer system is now generally considered to be a function of system complexity, patient/product impact, and pedigree (Configurable-Off-The-Shelf or Custom-written for a certain purpose). A lower risk system should merit a less in-depth specification/testing/validation approach. (e.g. The documentation surrounding a spreadsheet containing a simple but "GxP" critical calculation should not match that of a Chromatography Data System with 20 Instruments)

Determination of a "GxP critical" requirement for a computer system is subjective, and the definition needs to be tailored to the organisation involved. However, in general a "GxP" requirement may be considered to be a requirement which leads to the development/configuration of a computer function which has a direct impact on patient safety, the pharmaceutical product being processed, or has been developed/configured to meet a regulatory requirement. In addition if a function has a direct impact on GxP data (security or integrity) it may be considered "GxP critical".

## Product life cycle approach in validation

Validation process efforts must account for the complete product life cycle, including developmental procedures adapted for qualification of a drug product commencing with its research and development phase, rationale for adapting a best fit formula which represents the relationship between required outputs and specified inputs, and procedure for manufacturing. Each step is required to be justified and monitored in order to provide a good quality food and drug product. The FDA emphasizes the product life cycle approach in its evaluation of manufacturer regulatory compliance as well.

Bibliography  * Health Canada Validation Guidelines
* Akers, J. (1993), 'Simplifying and improving Process Validation', Journal of Parenteral Science and Technology, vol. 47, no. 6, pp. 281–284.
* ASTM E2537 Guide for Application of Continuous Quality Verification for Pharmaceutical and Biopharmaceutical Manufacturing
* EMEA (1998), EUDRALEX Volume 4 – Medicinal Products for Human and Veterinary Use : Good Manufacturing Practice, European Medicines Agency, London
* European Commission Enterprise Directorate-General (2001), Final Version of Annex 15 to the EU Guide to Good Manufacturing Practice, *Qualification and Validation*, Brussels. European Commission Enterprise Directorate-General.
* US FDA: Guideline on general principles of Process Validation
* Part 11: Electronic Records; Electronic Signatures,Code of Federal Regulations
* Garston Smith, H. (2001), 'Considerations for Improving Software Validation', Journal of Validation Technology, vol. 7, no. 2, pp. 150–157.
* IT Pharma Validation Europe: News and Updates on Computer System Validation and Infrastructure Qualification – e.g. EudraLex Volume 4 – Annex 11 computerised systems – revision January 2011
* Lopez, Orlando (2002), “21 CFR Part 11 – A Complete Guide to International Compliance,” published by Sue Horwood Publishing Limited.
* McDowall, R. D. (2005), 'Effective and practical risk management options for computerised system validation', The Quality Assurance Journal, vol. 9, no. 3, pp. 196–227.
* Parker G, (2005) ‘Developing Appropriate Validation and Testing Strategies’ *Presented for Scimcon Ltd at the Thermo Informatics World Conference*. North America.
* Powell-Evans, K. (1998), 'Streamlining Validation', Pharmaceutical Technology Europe, vol. 10, no. 12, pp. 48–52.
* Segalstad, S.H (2008), ‘*International IT Regulations and Compliance: Quality Standards in the Pharmaceutical and Regulated Industries*, John Wiley & Sons , pp. 157 – 178.
* Swartz, M. (2006) ‘Analytical Instrument Qualification’, Avanstar \[online\], available at: http://www.advanstar.com/test/pharmascience/pha-sci\_supp-promos/phasci\_reg\_guidance/articles/Instrumentation1\_Swartz\_rv.pdf (Accessed 29 March 2009).
* Validating Software used for the Pharmaceutical Industry. (2007). Retrieved July 6, 2009, from http://www.plainsite.net/validation/validation.htm
* WHO Technical Report Series, No. 937, 2006. Annex 4. Appendix 5. 2006
* Wingate, G.A.S. (2004), 'Computer Systems Validation: Quality Assurance, Risk Management, and Regulatory Compliance for the Pharmaceutical and Healthcare Industry', Interpharm Press.

* Guidance for Industry. Process Validation: General Principles and Practices. U.S. Department of Health and Human Services Food and Drug Administration. January 2011.


title: Valérie Batut

abstract: Valérie Batut is a French former professional tennis player. Batut, a native of Gueugnon, reached a career high ranking of 243 while competing on the professional tour, with qualifying draw appearances to her name at the French Open and Wimbledon. She twice featured in the singles main draw of the Strasbourg WTA Tour tournament, where in 1990 she won her first round match over Jo-Anne Faull, who was at the time ranked in the world's top 100.

text:
# Valérie Batut

**Valérie Batut** (born 12 October 1969) is a French former professional tennis player.

Batut, a native of Gueugnon, reached a career high ranking of 243 while competing on the professional tour, with qualifying draw appearances to her name at the French Open and Wimbledon. She twice featured in the singles main draw of the Strasbourg WTA Tour tournament, where in 1990 she won her first round match over Jo-Anne Faull, who was at the time ranked in the world's top 100.

## ITF finals

### Singles: 2 (0–2)

| Outcome | No. | Date | Tournament | Surface | Opponent | Score |
| --- | --- | --- | --- | --- | --- | --- |
| Runner-up | 1. | 19 March 1989 | Ashkelon, Israel | Hard | Marianne van der Torre | 6–2, 4–6, 4–6 |
| Runner-up | 2. | 29 October 1989 | Burgdorf, Switzerland | Carpet | Elena Brioukhovets | 4–6, 1–6 |

## InfoBox

Valérie Batut
| Country (sports) | France |
| --- | --- |
| Born | (1969-12-10) 10 December 1969 |
| Prize money | $17,253 |
| Singles | |
| Career record | 41–61 |
| Highest ranking | No. 243 (23 Jul 1990) |
| Grand Slam singles results | |
| French Open | Q2 (1989) |
| Wimbledon | Q1 (1989, 1990) |
| Doubles | |
| Career record | 5–15 |
| Highest ranking | No. 552 (7 Jan 1991) |


title: Van Denbergh-Simmons House

abstract: Van Denbergh-Simmons House is a historic home located at Colonie in Albany County, New York. The house was in three phases: the northeast section was built between about 1720 and 1760; the northwest section about 1790; and the south section about 1847. The northeast section is a 1+1⁄2-story Dutch house with a 1-story porch. The northwest section is a 1+1⁄2-story ell containing a large kitchen and bee hive oven. The south section is a 2-story Italian Villa style addition with a hipped roof and large square tower at the northwest corner. Also on the property are the remains of a barn foundation. It was listed on the National Register of Historic Places in 1985.

text:
# Van Denbergh-Simmons House

**Van Denbergh-Simmons House** is a historic home located at Colonie in Albany County, New York. The house was in three phases: the northeast section was built between about 1720 and 1760; the northwest section about 1790; and the south section about 1847. The northeast section is a 1+12-story Dutch house with a 1-story porch. The northwest section is a 1+12-story ell containing a large kitchen and bee hive oven. The south section is a 2-story Italian Villa style addition with a hipped roof and large square tower at the northwest corner. Also on the property are the remains of a barn foundation.

It was listed on the National Register of Historic Places in 1985.

## InfoBox

|  | |
| --- | --- |
| Van Denbergh-Simmons House | |
| U.S. National Register of Historic Places | |
|  | |
|  | |
| Location | 537 Boght Rd., Colonie, New York |
| Coordinates | 42°47′7″N 73°44′5″W / 42.78528°N 73.73472°W / 42.78528; -73.73472 |
| Area | 2 acres (0.81 ha) |
| Architectural style | Mixed (more Than 2 Styles From Different Periods) |
| MPS | Colonie Town MRA |
| NRHP reference No. | 85002751 |
| Added to NRHP | October 3, 1985 |


title: Van Den Bosch syndrome

abstract: van Den Bosch syndrome is a rare X-linked syndrome like intellectual disability. It may be caused by a small X-chromosome deletion. The condition can be detected around infancy.

text:
# Van Den Bosch syndrome

**van Den Bosch syndrome** is a rare X-linked syndrome like intellectual disability. It may be caused by a small X-chromosome deletion.

The condition can be detected around infancy.

## Epidemiology

According to Orphanet the condition occurs in 1 in 1 million people.

It has been reported in only one family.

## Symptoms

Symptoms for the condition include.

* Abnormal electroretinogram
* Acrokeratosis
* Anhidrotic ectodermal dysplasia
* Choroideremia
* Heat intolerance
* High myopia
* Horizontal nystagmus
* Intellectual disability
* Recurrent respiratory infections
* Recurrent skin infections
* Scapular winging
* Unfavorable response of muscle weakness to acetylcholine esterase inhibitors
* skeletal abnormality
* Anhidrosis
* Contiguous gene syndrome
* X-linked inheritance

## History

It was first described by J. Van den Bosch in 1959. He reported the condition in 2 brothers. The condition was found in more males spanning three generations. According to Orphanet there have been no more descriptions in literature since 1959.

## InfoBox

| Van Den Bosch syndrome | |
| --- | --- |
| Other names | Mental deficiency, choroideremia, acrokeratosis verruciformis, anhidrosis, skeletal deformity |


title: Vanilla (film)

abstract: Vanilla is a 2018 Indian Kannada-language mystery film directed by Jayatheertha and starring newcomers Avinash J and Swathi Konde along with Ravishankar Gowda.

text:
# Vanilla (film)

***Vanilla*** is a 2018 Indian Kannada-language mystery film directed by Jayatheertha and starring newcomers Avinash J and Swathi Konde along with Ravishankar Gowda.

## Cast

## Soundtrack

The music was composed by Bharath B. J.

| Song | Lyricist | Singer(s) |
| --- | --- | --- |
| "Aavarisu Baa Mellane" | Madan Bellisalu | Vijay Prakash, Inchara Nagesh |
| "Eduredurali" | Arjun Luis | Eesha Suchi, Ashwin Sharma |
| "Onde Mathalli" | Jayant Kaikini | Rajesh Krishnan |
| "Theme Of Vanilla" |  | Instrumental |
| "Eravalu Kodu" | Jayanth Kumar T V | Eesha Suchi, Ashwin Sharma |

## Reception

A critic from *Deccan Herald* gave the film a rating of four out of five stars and wrote that "*Vanilla* has gripping sequences, fine and believable twists". A critic from *The Times of India* wrote that "If you are in the mood to play Sherlock, make a trip to the theatre to solve the Vanilla mystery". A critic from *The Hindu* wrote that "The director deserves appreciation for experimenting with a new theme with a new approach".

## InfoBox

| Vanilla | |
| --- | --- |
| Release poster | |
| Directed by | Jayatheertha |
| Produced by | Jairaj |
| Starring | Avinash J
Swathi Konde
Ravishankar Gowda |
| Music by | Bharath B. J. |
| Production
company | Akhila Productions |
| Release date | * 1 June 2018 (2018-06-01) |
| Country | India |
| Language | Kannada |


title: Vanilla (group)

abstract: Vanilla were a British pop girl group from Barnet, London, England, formed in 1996.

text:
# Vanilla (group)

**Vanilla** were a British pop girl group from Barnet, London, England, formed in 1996.

## History

The band members were sisters Frances and Alison Potter, Alida Swart and Sharon Selby. They released two singles for EMI in the late 1990s.

The band's first single was "No Way, No Way", released in December 1997 and based on Piero Umiliani's "Mah Nà Mah Nà". The song peaked at number 14 on the UK Singles Chart and number 24 in New Zealand. It was later featured on several compilations, including *Now That's What I Call Music!* volume 39 and *Dancemania 8*, both released in 1998. The accompanying music video was filmed at Brockwell Lido in Brixton, South London. The clip won the title of "Worst Music Video Ever" on the 1997 ITV Chart Show end-of-year special and was voted number 26 on Channel 4's "100 Worst Pop Records". The follow-up was "True to Us", released in April 1998, which rose to number 36 in the UK. Although mocked on Channel 4's morning programme *The Big Breakfast*, the group regularly took part in the show's "Vanilla's Thrillers" feature, including making a return for Johnny Vaughan and Denise van Outen's final week hosting the show.

While promoting their two singles with EMI, Vanilla made media appearances, including a performance of "No Way, No Way" on *Top of the Pops*, and performing a spoof version of "True to Us" on *Blue Peter*. They also obtained a feature on *Men & Motors*. They embarked on a tour of schools around the UK and were a minor act on the 1998 Disney Channel UK tour. After their contract with EMI ended, Vanilla continued to perform. They made various appearances at London's PopShow Party events where they played a cover of Nancy Sinatra's "These Boots Are Made for Walkin'" as well as promotional single "Realise", with temporary member Ashley.

In 2011, Frances appeared on the identity parade segment in Episode No. 25.8 of *Never Mind the Buzzcocks*, hosted by James Blunt. In 2014, Swart was interviewed for an article in *The Guardian* about the pitfalls of having a hit novelty record.

In 2021, an EP titled *Vanilla* containing promotional single "Realise" and two other tracks was briefly released to digital music outlets.

## Discography

| Single title | UK | NZ | SC |
| --- | --- | --- | --- |
| "No Way No Way" | 14 | 24 | 12 |
| "True to Us" | 36 |  | 32 |
| *Vanilla EP* |  |  |  |

## InfoBox

| VANILLA | |
| --- | --- |
| Girl group VANILLA | |
| Background information | |
| Origin | Barnet, London, England |
| Genres | Pop |
| Years active | 1996–1998 |
| Labels | EMI |
|  | |
| Past members | Frances Potter
Alison Potter
Alida Swart
Sharon Selby |


title: Vallco Professional Drag Racing

abstract: Vallco Professional Drag Racing is a card-based drag racing game invented by Greg Zyla originally in 1963. The game was inspired in part by Strat-O-Matic baseball and LeMans racing board games. It combined cards with die rolls. Zyla's prototype game used statistics for "Dyno Don" Nicholson, Ronnie Sox, Gas Ronda, Hayden Proffitt, Dick Brannan, Dave Strickler, and some other Pro Stock and A/FX racers. Burnouts were governed by die rolls, also. NHRA required Zyla to get signed releases from every driver involved. Only Don "The Snake" Prudhomme's lawyer sought a licensing fee; when Zyla revealed he was a mere "mom and pop" operator, Prudhomme wished him luck. When it reached the market in 1975, the game offered only Pro Stock drivers, relying on their 1974 season's statistics. There were also anonymous cards, for players who wanted to race, themselves. The game accounted for changing track conditions and oildowns, as well as the latest NHRA rules. Zyla's first advertisement was in National Dragster in 1975. By 1977, Zyla had added Top Fuel Funny Car and Dragster drivers. Later editions added Pro Comp, for one year only; the statistics cards for Pro Comp are now hard to find. A 1976 piece by Woody Hatten in Super Stock & Drag Illustrated magazine garnered national attention. Some professional racers, including Bob Glidden, Al Hanna, and "Dandy Dick" Landy, also played. Priced at $8.95 when originally released, the price rose as high as $16.95 before it went out of production in 1980. Approximately 3000 copies were sold. Inventor Zyla continues to write two weekly syndicated columns for Gannett and GateHouse Media, one a test-drive column and one a collector car/motorsports column as of July 29, 2020. He did build his own race car from the proceeds of the game in 1979, and had two successful seasons driving his gas powered Vega Panel Wagon funny car. He was the Top Winner in 1980 at Numidia Dragway in Pennsylvania in 1980 scoring six wins and three runner ups in 18 races. See his homepage for examples of his current work, photos, interviews, etc. at zylamotorsports.com or at gregzyla.com.

text:
# Vallco Professional Drag Racing

**Vallco Professional Drag Racing** is a card-based drag racing game invented by Greg Zyla originally in 1963.

The game was inspired in part by Strat-O-Matic baseball and LeMans racing board games. It combined cards (containing driver statistics, including averaged e.t.s, wins, losses, holeshot wins and losses, and breakage rates) with die rolls (four *per* race). Zyla's prototype game used statistics for "Dyno Don" Nicholson, Ronnie Sox, Gas Ronda, Hayden Proffitt, Dick Brannan, Dave Strickler, and some other Pro Stock and A/FX (pre-Funny Car) racers. Burnouts were governed by die rolls, also.

NHRA required Zyla to get signed releases from every driver involved. Only Don "The Snake" Prudhomme's lawyer sought a licensing fee; when Zyla revealed he was a mere "mom and pop" operator, Prudhomme wished him luck.

When it reached the market in 1975, the game offered only Pro Stock drivers (31 in all), relying on their 1974 season's statistics. There were also anonymous cards, for players who wanted to race, themselves.

The game accounted for changing track conditions and oildowns, as well as the latest NHRA rules.

Zyla's first advertisement was in *National Dragster* in 1975.

By 1977, Zyla had added Top Fuel Funny Car (including East Coast match racers like Tim Kushi) and Dragster drivers. Later editions added Pro Comp, for one year only; the statistics cards for Pro Comp are now hard to find.

A 1976 piece by Woody Hatten in *Super Stock & Drag Illustrated* magazine (based on the experience of a group who played the game on a regular basis, of which Hatten was a member) garnered national attention. Some professional racers, including Bob Glidden, Al Hanna, and "Dandy Dick" Landy (who purchased six copies), also played.

Priced at $8.95 when originally released, the price rose as high as $16.95 before it went out of production in 1980. Approximately 3000 copies were sold.

Inventor Zyla continues to write two weekly syndicated columns for Gannett and GateHouse Media, one a test-drive column and one a collector car/motorsports column as of July 29, 2020. He did build his own race car from the proceeds of the game in 1979, and had two successful seasons driving his gas powered Vega Panel Wagon funny car. He was the Top Winner in 1980 at Numidia Dragway in Pennsylvania in 1980 scoring six wins and three runner ups in 18 races. See his homepage for examples of his current work, photos, interviews, etc. at zylamotorsports.com or at gregzyla.com.


title: Vallclara

abstract: Vallclara is a village in the province of Tarragona and autonomous community of Catalonia, Spain.

text:
# Vallclara

**Vallclara** (Catalan pronunciation: \[ˌbaʎˈklaɾə\]) is a village in the province of Tarragona and autonomous community of Catalonia, Spain.

## InfoBox

| Vallclara | |
| --- | --- |
| Municipality | |
|  | |
|  | |
| VallclaraLocation in Catalonia | |
| Coordinates: 41°22′59″N 0°59′00″E / 41.383°N 0.9833°E / 41.383; 0.9833 | |
| Country | Spain |
| Autonomous community | Catalonia |
| Province | Tarragona |
| Comarca | Conca de Barberà |
| Government | |
| Mayor | Rosendo Roig Nadal (2015) |
| Area | |
| Total | 13.6 km2 (5.3 sq mi) |
| Population (2018) | |
| Total | 98 |
| Density | 7.2/km2 (19/sq mi) |
| Time zone | UTC+1 (CET) |
| Summer (DST) | UTC+2 (CEST) |
| Website | www.vallclara.altanet.org |


title: Varicostele

abstract: Varicostele is a genus of air-breathing land snails, terrestrial pulmonate gastropod mollusks in the family Streptaxidae.

text:
# Varicostele

***Varicostele*** is a genus of air-breathing land snails, terrestrial pulmonate gastropod mollusks in the family Streptaxidae.

## Distribution

The distribution of the genus *Varicostele* includes:

## Species

Species within the genus *Varicostele* include:

## InfoBox

| *Varicostele* | |
| --- | --- |
|
| Scientific classification | |
| Kingdom: | Animalia |
| Phylum: | Mollusca |
| Class: | Gastropoda |
| (unranked): | clade Heterobranchia clade Euthyneura
clade Panpulmonata
clade Eupulmonata
clade Stylommatophora

informal group Sigmurethra |
| Superfamily: | Streptaxoidea |
| Family: | Streptaxidae |
| Subfamily: | Enneinae |
| Genus: | ***Varicostele***
Pilsbry, 1919 |
|


title: Vasco-Cantabria

abstract: Vasco-Cantabria, in archaeology and the environmental sciences, is an area on the northern coast of Spain. It covers similar areas to the northern parts of the adjacent modern regions of the Basque country and Cantabria. In geology the "Vasco-Cantabrian Basin" or "Basque-Cantabrian Basin" covers the area and the seas off the coast in the Bay of Biscay, an area between the Iberian and European tectonic plates. The area is of special significance in the archaeology of the Upper Palaeolithic, Epipalaeolithic and Mesolithic periods of the Stone Age. A narrow coastal strip was a glacial refugium, never covered by glaciers during the Last Glacial Maximum, and appears to have been densely populated. It is part of the wider Franco-Cantabrian region that stretches from Asturias, the next region west of Cantabria, to Provence in southeastern France. The main archaeological industries in the area during this period are the Middle Paleolithic Mousterian, the Upper Paleolithic Chatelperronian, Aurignacian, Gravettian, Solutrean, Magdalenian, and then the Azilian, which is variously classified as Late Paleolithic, Epipalaeolithic and Mesolithic. Vasco-Cantabrian sites contain much of the surviving art of the Upper Paleolithic, especially in terms of cave paintings. The UNESCO World Heritage Site "Cave of Altamira and Paleolithic Cave Art of Northern Spain" consists of ten caves in Cantabria and three in the Basque County, as well as five from Asturias.

text:
# Vasco-Cantabria

**Vasco-Cantabria**, in archaeology and the environmental sciences, is an area on the northern coast of Spain. It covers similar areas to the northern parts of the adjacent modern regions of the Basque country and Cantabria. In geology the "Vasco-Cantabrian Basin" or "Basque-Cantabrian Basin" covers the area and the seas off the coast in the Bay of Biscay, an area between the Iberian and European tectonic plates.

The area is of special significance in the archaeology of the Upper Palaeolithic, Epipalaeolithic and Mesolithic periods of the Stone Age. A narrow coastal strip was a glacial refugium, never covered by glaciers during the Last Glacial Maximum, and appears to have been densely populated. It is part of the wider Franco-Cantabrian region (also *Franco-Cantabric region*) that stretches from Asturias, the next region west of Cantabria, to Provence in southeastern France.

The main archaeological industries in the area during this period are the Middle Paleolithic Mousterian, the Upper Paleolithic Chatelperronian, Aurignacian, Gravettian, Solutrean, Magdalenian, and then the Azilian, which is variously classified as Late Paleolithic, Epipalaeolithic and Mesolithic. Vasco-Cantabrian sites contain much of the surviving art of the Upper Paleolithic, especially in terms of cave paintings. The UNESCO World Heritage Site "Cave of Altamira and Paleolithic Cave Art of Northern Spain" consists of ten caves in Cantabria and three in the Basque County, as well as five from Asturias.

## Flora and fauna

The region is and was part of the Eurosiberian climatic zone, and remained relatively moist throughout the period, unlike much of Spain. In the relevant period common trees included birch, Scots pine, beech, juniper and willow, all of which fluctuated with changes in temperature. The animal remains commonly found at human sites include red deer, aurochs, ibex, horse and goats. Reindeer are rare, unlike in southern France.

During this period the climate fluctuated, and warmer periods brought a great increase in forest cover, changing the populations of larger animals, with herd animals preferring a more open landscape, notably bison, horse and red deer, giving way to "smaller, less gregarious game", such as wild boar and roe deer. At the start of the Holocene, a rise in sea levels considerably reduced the width of the coastal strip, taking some 6–16 km from a strip that had only been 25–50 km wide between the sea to the north and the Cantabrian Mountains and their glaciers, which lie to the south of the whole region.

## Selected archaeological sites

### Cantabria

### Basque Country

* Straus (1996): Straus, Lawrence Guy, Valentin Eriksen, Jon M. Erlandson, and David R. Yesner, eds. *Humans at the end of the Ice Age: the archaeology of the Pleistocene-Holocene Transition.*\] New York: Plenum Press, 1996:346. ISBN 0-306-45177-8, google books
* Straus (2008): Straus, Lawrence Guy, in Bailey, Geoff and Spikins, Penny, *Mesolithic Europe*, 2008, Cambridge University Press, ISBN 0521855039, 9780521855037
* Straus (2013): Straus, Lawrence Guy, Chapter 7 in *Zooarchaeology and Modern Human Origins: Human Hunting Behavior during the Later Pleistocene*, eds. Jamie L. Clark, John D. Speth, 2013, Springer, ISBN 9400767668, 9789400767669, google books


title: Vaughn Telemaque

abstract: Vaughn Telemaque is a former American football safety. He is a graduate of the University of Miami.

text:
# Vaughn Telemaque

**Vaughn Telemaque** (born March 4, 1990) is a former American football safety. He is a graduate of the University of Miami.

## High school career

As a senior in 2007, Telemaque made 89 tackles and nine interceptions, two sacks, forced four fumbles and returned a fumble for a touchdown. In his team's Division I championship victory he had 110 tackles and three interceptions. As a junior in 2006, Telemaque made 52 tackles and two interceptions.

Telemaque was a PrepStar All-American who was ranked as the No. 12 safety and the No. 171 player in the country by *Rivals.com*. He was rated the No. 6 safety, the No. 12 player in California, and the No. 100 player in the nation by Scout.com. Telemaque was selected as the No. 17 safety by ESPN and was selected to EA Sports second-team All-America.

## College career

As a true freshman in 2008, Telemaque played in the first three games of the season against Charleston Southern, Florida, and Texas A&M, before missing the remainder of the season with an injury. Telemaque participated on the scout team for the rest of the season and was awarded a medical hardship to be a redshirt freshman in 2009.

Playing as a redshirt freshman in 2009, Telemaque ranked fifth on the Miami Hurricane defense with 48 total tackles. In the Hurricanes' win over No. 8 Oklahoma, Telemaque recorded career-highs for total tackles (9) and solo stops (6). In the 2009 Champs Sports Bowl against Wisconsin, Telemaque matched a career-high in total tackles (9) and set a career-high in assisted tackles (5).

As a Sophomore in 2010, Telemaque was one of seven Canes to start all 13 games on the year and was fourth on team with 58 tackles. He tied for team lead in interceptions with three, including two interceptions against Duke. Telemaque led the team with three fumble recoveries and recorded a season-high seven tackles against both Florida State and Virginia.

For his junior season in 2011, Telemaque Started all 12 games at safety and finished fourth on the team in tackles with 59 (36 solo, 23 assists). He recorded one interception on the year in the season opener against Maryland. Telemaque also registered a season-high eight tackles against the Terrapins and led the team with seven tackles against Florida State and seven tackles against Boston College.

In his senior season in 2012, Telemaque played in 10 games, making two starts. He tallied 20 tackles (10 solo) and one forced fumble and was of six Hurricanes to earn All-ACC honorable mention from league coaches. Telemaque had five tackles in each of season's first two games at Boston College and at Kansas State.

## InfoBox

Vaughn Telemaque
| No. 7 | |
| --- | --- |
| Position: | Safety |
| Personal information | |
| Born: | (1990-03-04) March 4, 1990<br>Long Beach, California |
| Height: | 6 ft 1 in (1.85 m) |
| Weight: | 185 lb (84 kg) |
| Career information | |
| High school: | Long Beach (CA) Poly |
| College: | Miami (FL) |
| Undrafted: | 2013 |
|  | |


title: Veerachcholai

abstract: Veerachcholai is a rural village in the Ampara District within the Eastern Province of Sri Lanka. Most residents are Sri Lankan Tamilians, a minority and are farmers.

text:
# Veerachcholai

**Veerachcholai** is a rural village in the Ampara District within the Eastern Province of Sri Lanka. Most residents are Sri Lankan Tamilians, a minority and are farmers.

## History

According to local chronicles, Veeramunai was founded by early settlers in a medieval feudal division known as Nadukadu. This took place during the pre-colonial period (prior to 1505 CE). Feudal lords known as Vanniar (resident in the village) controlled large swaths of farmland surrounding the village. These farm holdings led to conflicts with the residents of the larger nearby town of Sammanthurai. A majority of the residents of Sammathurai were members of the Sri Lankan Muslim minority, which added to the conflict.

In 1954, after a local conflict, a mob from Sammanthurai burned Veeramunia. About 75% of the villagers left Veeramunai and set up satellite settlements such as Malwattai, Kanapathipuram and Veerachcholai at a safe distance from Sammanthurai. Veeramunai land holdings were eventually sold to residents of Sammanthurai and, consequently, the village declined in size and population.

During the 1990s, villagers were further disrupted by the insurgency and counter-insurgency operations of the Sri Lankan Civil War. On August 12, 1990, Veeramunai refugees who were taking cover within the Hindu temple at Veeramunai were attacked by Home Guards from Sammanthurai, resulting in the death of 55 civilians. Eventually, the village was resettled by returning refugees.

## InfoBox

| Veerachcholai | |
| --- | --- |
| Village | |
| Veerachcholai | |
| Coordinates: 7°22′0″N 81°45′0″E / 7.36667°N 81.75000°E / 7.36667; 81.75000 | |
| Country | Sri Lanka |
| Province7 | Eastern |
| District | Ampara |


title: Vauxhall railway station (Merseyside)

abstract: Vauxhall railway station is a proposed railway station in the Vauxhall area of Liverpool. If it is constructed it will be sited between Moorfields and Sandhills on the Merseyrail Northern Line. Construction of the new station was proposed in January 2017 by Mayor of Liverpool Joe Anderson, as part of the city's North Docks project and also Everton Football Club's potential plans to build their new stadium in the area.

text:
# Vauxhall railway station (Merseyside)

**Vauxhall railway station** is a proposed railway station in the Vauxhall area of Liverpool. If it is constructed it will be sited between Moorfields and Sandhills on the Merseyrail Northern Line. Construction of the new station was proposed in January 2017 by Mayor of Liverpool Joe Anderson, as part of the city's North Docks project and also Everton Football Club's potential plans to build their new stadium in the area.

| Preceding station | National Rail | | | Following station |
| --- | --- | --- | --- | --- |
| Sandhills |  | Merseyrail
Northern Line |  | Moorfields |

## InfoBox

| Vauxhall (Merseyside) | |
| --- | --- |
| General information | |
| Location | Vauxhall, Liverpool
England |
| Managed by | Merseyrail |
| Transit authority | Merseytravel |
| Platforms | 2 |
| Key dates | |
| 2017 | Proposed |
|  | |
|  | |
|  | |


title: Veena Venkatagiriyappa

abstract:
Veene Venkatagiriyappa was a musician and music teacher from Heggadadevanakote in the Mysore district of India. Venkatagiriyappa's initial musical training was under his uncle Chikka Subba Rao, and he later studied under and was greatly influenced by Veene Sheshanna. He was also exposed to western classical music by the director of the orchestra maintained by the Maharaja. Venkatagiriyappa later compiled a collection of Carnatic classical compositions rendered using Western musical notation. Venkatagiriyappa was an Asthana Vidwan(Court Musician) of the Mysore Darbar, and composed many carnatic classical songs in Western Style. His famous compositions include:
1) Sharadhe Shubrahare
2) Nagma
many more His Son Veenapraveena Vidwan Srinivas Prasanna is also a renowned Veena Player.

text:
# Veena Venkatagiriyappa

**Veene Venkatagiriyappa** (26 April 1887 – 1951) was a musician and music teacher from Heggadadevanakote in the Mysore district of India.

Venkatagiriyappa's initial musical training was under his uncle Chikka Subba Rao, and he later studied under and was greatly influenced by Veene Sheshanna. He was also exposed to western classical music by the director of the orchestra maintained by the Maharaja. Venkatagiriyappa later compiled a collection of Carnatic classical compositions rendered using Western musical notation.

Venkatagiriyappa was an Asthana Vidwan(Court Musician) of the Mysore Darbar, and composed many carnatic classical songs in Western Style.

His famous compositions include: 1) Sharadhe Shubrahare (Raga Sharadapriya) 2) Nagma (Ragas: Hindola, Keeravani, Behaag) many more

His Son Veenapraveena Vidwan Srinivas Prasanna is also a renowned Veena Player.

## Sources

* "Sangita Samaya", by S Krishnamurthy