FAQs

Q

cGxP Explainer

A

GxP-where the “x” is used as an umbrella letter in representing different subjects or disciplines in industry.  For example GLP (Good Laboratory Practice) GDP, (Good Documentation Practice) and GEP (Good Engineering Practice) and GMP (Good Manufacturing Practices) Furthermore, the use of a lower case “c” as a prefix indicates “current” or “up-to-date”.  So cGDP stands for “Current Good Documentation Practices. This means that some conventions or practices are subject to change over time within the industry. Therefore, it is important to be up-to-date in the application of cGxP or cGDP.

Q

Validation Plans

A

Types of Validation Plans

  1. Site Master Validation Plan
  2. Master Validation Plan
  3. Individual Validation Plan 

Site Master Validation Plan

A Site MVP details the Products, Processes and associated Validation Protocols and reports for a Manufacturing site/factory. It is the over-archiving validation plan. Typical Site MVP includes:

Description of products & processes, test methods (analytical, physical), specifications, an up-to-date list of utility qualifications, equipment qualifications, process validations.

Master Validation Plan

A MVP encompasses all aspects of a validation strategy where multiple processes, equipment/machines require validation. MVP s are common for New Product Introductions. Although not stated in 21 CFR Part 820 MVPs are an important requirement to document the validation status.

Individual Validation Plan

Individual Validation Plans document the validation strategy or general approach to qualification for a particular system, piece of equipment or Process. Individual Validation Plans are also used for Projects which fall outside of the day to day validation requirements.

For simple equipment the Validation Plan may be documented in the Qualification protocol.

 

View our selection of Templates here.  

Q

What Are The Four Types of Process Validation?

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Process validation is a regulatory requirement of Good Manufacturing Practices (GMPs) for both pharmaceuticals (21CFR 211) and medical devices (21 CFR 820)

Process Validation is defined as “establishing documented evidence which provides a high degree of assurance that a specific process consistently produces a product meeting its predetermined specifications and quality attributes.”

Prospective validation

Establishing documented evidence in advance of process implementation that a process or system operates as intended. This is the preferred approach and is most common when new products must be validated before commercial manufacturing.

Concurrent validation

Establishing documented evidence that a processes operates as intended, based on information generated during process implementation. Concurrent means that the outputs are performance of the system is monitored at the same time a manufacturing which can include commercial lots.

Retrospective validation

Retrospective validation is used for facilities or processes that have not completed formal Validation. Historical data or a retrospective review can provide the evidence that the process or facility is operated as intended. This type of validation is uncommon.

Revalidation

Revalidation involves the re-execution of validation activities in order to maintain a validated state. This can be a result of substantial changes to Product attributes or specification or changes to the manufacturing process itself. Other reasons a partial or full revalidation may be required involve instances where product quality issues have increased.

Q

What are the Key elements to Test Method Validation?

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Test Method Validation is critical to the success of any product or process. As Validated Test Methods are used to verify the outputs of your process, if they are unsuitable or do not meet industry standards you will waste your time chasing ghosts or going after the wrong information.

Industry Standards are key to developing suitable and robust test methods. Standards are not necessarily mandatory, but offer best practice and make engineering sense when implementing a new test method.

Your Test Method Validation should address the following:

  • Accuracy
  • Precision
  • Repeatability and Reproducibility
  • P/T Ratio
  • Range and Resolution
  • Product Specifications
  • Method Ruggedness/Robustness
View our recommended book on Test Method Validation Click here

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Q

Why Outsource Validation?

A

It has been my experience over the past number of years, that companies are eliminating “Validation Departments” in their traditional sense.  Increasingly the Quality Engineer or Quality Manager is owner of validation activities. While there are advantages of this approach, an alternative is to outsource to individual contractors or agencies.

I believe that there is room for a more radical approach as it were. In my way of thinking, Validation is a very logical and iterative process. Procedures and templates are in place and to be followed. A great deal of the Validation pre-requisites prior to execution of a Process validation can be done offline and offsite. If this is an option for a company, it can reduce cost via outsourcing, only requiring a minimum amount of time onsite. To put it simply, it can be a flexible alternative.

Regards,

Validation Resources.