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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The Similarity Between Device Master Records & Chocolate Chip Cookies [Video]

The device design once complete, must be adequately transferred to manufacturing. This is typically accomplished through product specifications, standard operating procedures, work instructions and training.

Collection of Documents

Often a product specification is thought of as a document. The reality is the product specifications should be thought of as an association of written documents.

The product specifications typically include:

  • Assembly drawings
  • Component procurement specifications
  • Manufacturing instructions
  • Inspection
  • Test instructions
  • Digital data files
  • Manufacturing fixtures (jigs and molds)
  • Training materials
  • Artwork associated with labels
  • Acceptance criteria
  • Etc

Device Master Record (DMR)

The ultimate document to ensure adequate design transfer is the Device Master Record, or DMR.

The DMR is somewhat theoretical in that it is really a compilation of all the documents which are needed to realize the product.

For that reason, the DMR, is often established as an index which simply lists all of the documents needed to realize the product.

Contents of the DMR

The DMR typically includes the following documents:

  • Product specifications
  • Work instructions for device realization
  • Device history records/Forms to generate device history records
  • Component drawings/Specifications
  • Label artwork/Specifications
  • Test/Inspection methods
  • Software/Firmware
  • Validation Master Plan (VMP)

Since these documents may be revising and changing and may be at various distribution points, the DMR typically is an index of all the documents.

Chocolate Chip Cookie Analogy

One very common analogy is to envision the DMR as a chocolate-chip cookie recipe. If the DMR is complete, by providing the DMR to someone they can make the exact same chocolate-chip cookies.

While this is somewhat simplified, it’s an excellent analogy, but in order to make the perfect chocolate-chip cookie we would want specifications for the grade of flour, chocolate chips, sugar and other components.

We’d also like to know which equipment was validated, how they are tested/inspected, what are the instructions for each processing step, etc.

If we have all the relevant information we can reproduce the cookies exactly.

The DMR is the key to any successful design transfer whether it is an internal transfer to manufacturing or a transfer to a Contract Manufacturing Organization (CMO).

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The Four Phases of Conducting a Laboratory Investigation [Video]

The process which will be described here is based on the process discussed in the MHRA’s guidance on Out of Specifications Investigation.

When an out of specification, atypical or suspect result is obtained, it is particularly important that all solutions and reagents associated with the test are retained, as this will greatly assist the investigation.

The MHRA advocate laboratory investigations should proceed in four phases as follows:

Phase I(a)

Phase I (a) consists of a preliminary review, by the analyst, to determine whether there has been a clear and obvious error or event that caused the OOS, atypical or suspect result.

Phase I(b)

Phase I (b) occurs after phase 1(a) has failed to identify a clear and obvious cause. This is a more detailed investigation by the analyst and supervisor to identify a laboratory assignable cause.

Phase II

Phase II occurs after the phase I investigation has failed to identify a laboratory assignable cause for the OOS, atypical or suspect result and are driven by written and approved instructions in order to test particular hypothesis.

Phase III

In Phase III all the information obtained during Phases I and II of the laboratory investigation, and any manufacturing investigation, is reviewed and assessed, and a decision is made on the disposition of the batch

Learn More About Laboratory Investigations

If you would like to learn more about laboratory investigations click here for an overview of this course.

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