New Forum – Good Automated Manufacturing Practice GAMP 5

AskaboutValidation is pleased to announce the creation of our brand new GAMP 5 forum. Good Automated Manufacturing Practice (GAMP) is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry.

Good Manufacturing Practices

More specifically, the ISPE’s guide The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture describes a set of principles and procedures that help ensure that pharmaceutical products have the required quality. One of the core principles of GAMP is that quality cannot be tested into a batch of product but must be built into each stage of the manufacturing process.

As a result, GAMP covers all aspects of production; from the raw materials, facility and equipment to the training and hygiene of staff. Standard operating procedures (SOPs) are essential for processes that can affect the quality of the finished product.
A group of pharmaceutical professionals have banded together to create the GAMP Forum, which is now a technical sub-committee, known as the GAMP COP (community of practice) of the International Society for Pharmaceutical Engineering (ISPE). The goal of the community is to promote the understanding of the regulation and use of automated systems within the pharmaceutical industry.

The GAMP COP organizes discussion forums for its members. ISPE organises GAMP-related training courses and educational seminars. Several local GAMP COPs, such as GAMP Americas, GAMP Nordic, GAMP DACH (Germany, Austria, Switzerland), GAMP Francophone, GAMP Italiano, GAMP Benelux (Belgium, Netherlands, Luxembourg) and GAMP Japan bring the GAMP community closer to its members in collaboration with ISPE’s local affiliates in these regions.

GAMP Guidance

ISPE has published a series of good practice guides for the industry on several topics involved in drug manufacturing. The most well-known is The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture. The last major revision (GAMP5) was released in February 2008.[2]

Other publications in the GAMP series include:

  • GAMP Good Practice Guide: A Risk-Based Approach to Compliant GxP Computerized Systems
  • GAMP Good Practice Guide: Calibration Management
  • GAMP Good Practice Guide: Electronic Data Archiving
  • GAMP Good Practice Guide: Global Information Systems Control and Compliance
  • GAMP Good Practice Guide: IT Infrastructure Control and Compliance
  • GAMP Good Practice Guide: Testing of GxP Systems
  • GAMP Good Practice Guide: Validation of Laboratory Computerized Systems
  • GAMP Good Practice Guide: Validation of Process Control Systems

Check Out Our New Forum


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To help you successfully validate a computer system remember the following:

1. Development Methodology

Select a development methodology that best suits the nature of the system – the risk analysis you do will help decide what level of validation is required.

For example, if you purchase the system from a third party vendor you may be able to leverage some of the testing they have already performed to streamline the effort.

2. Hardware

Select hardware based on capacity and functionality – vendors and IT personnel will guide this part of the process.

3. Opertional Limits

Identify operational limits to establish production procedures

4. Opertional Functions

Identify operational functions associated with the

  1. Users
  2. Processes
  3. Regulations
  4. Company standards
  5. safety requirements

5. Worst Case Scenrios

Identify and test worst-case production scenarios

6. Master Validation Plan

Clearly document the validation process and start by creating a master validation plan to define the effort involved

7. Written Procedures

Ensure the availability of written procedures to maintain the validated state of the computer system.

21 CFR Part 11 - Electronic Records

This video is taken from our online course on 21 CFR Part 11 – Electronic records. Click here to find out more about this course.


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The 9 Golden Rules – Ensuring Laboratory Data Integrity [Video]

The enduring assets of a laboratory’s work are the records that document those activities. When laboratory records are used to support a regulatory function, they are considered to be legal documents.

For records to be considered reliable and trustworthy they must comply with the following criteria:

1. Legible and Understandable

They must be able to be read and understood for the lifetime of the record, without having to refer to the originator for clarification. The information may be needed in five, ten or twenty years’ time, perhaps after the originator is no longer available.

2. Attributable

Who made the record or created the data and when?

3. Contemporaneous

The record must be made at the time the activity was performed

4. Original

The information must not be written on a post-it, piece of scrap paper, sleeve of a lab coat etc. and then transcribed.

5. Accurate

No errors or editing without documented amendments.

6. Complete

All the information and data associated with the analysis is included.

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All elements in the sequence of analysis must be date & time stamped and must be in the expected order.

8. Indelible

Records are made on to controlled documents, such as laboratory notebooks or controlled worksheets, or saved to electronic media.

9. Available

Over the entire lifetime of the record for review, audit and inspection.



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