Does your QC lab do GMP and non-GMP activities?

Why Should You Attend:

If a laboratory is dedicated either to GMP testing and validation activities or to method and procedure development and validation, then the laboratory is responsible for following the appropriate CFRs. GMP guidance’s for the pharmaceutical industry are included in 21 CFR, and for GLP guidance’s can be found in 58 CFR. However, if both types of work are being done in the same laboratory and even by the same analysts, it is critical to define boundaries. This involves not only the analysts and the laboratory management but extends to reviewers of critical documents and client education regarding the practices and policies.

Attend this 1-hr presentation webinar with your team to understand the pitfalls and risks of having GMP and GLP practices occurring in one location and strengthen the understanding of the lifecycle of a method or procedure.

Areas Covered in the Webinar:

• CFR guidance for GMP testing of pharmaceutical products.
• CFR guidance for GLP practices and method and procedure development.
• Product testing and regulatory requirements.
• The transition from a procedure in development to one used routinely.
• The use of test plans.
• Establishing boundaries.

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

• QC functions in general
• QC technical transfer groups
• QC validation groups
• Commercial testing facilities
• Product development
• QA reviewers who are responsible for both GMP and GLP documentation practices

Barbara Berglund
COO, CMC Turnkey Solutions

Barbara Berglund, has been working in the pharmaceutical and medical device industry, specifically with sterile parenteral dugs, for over 15 years. Her experience includes her current role as a QC Manager as well as roles in the laboratory, project management, and clinical trial manufacturing. The QC group she currently manages is directly responsible for testing of products used in support of the medical device industry; she previously managed a QC team responsible for procedure transfer and validation in support of parenteral pharmaceutical products. She has an undergraduate degree in Chemistry and post graduate degrees in Chemistry and Pharmacological and Physiological Science. She received her PMP certification in 2007 and her Green Belt certification in 2008.

Topic Background:

No matter which phase a drug product is in, pharmaceutical drug substance and drug product testing is a crucial element to move forward with decisions regarding either the use of the product or the procedures. During drug discovery, a number of procedures are actively being developed and put into place to determine the quality and efficacy of a drug substance or a drug product. The approach to developing new procedures is far different from validation of a known procedure. It is not uncommon at the early stages of development to utilize a test plan approach for procedure development, which is not aligned with GMP practices.

When performing quality testing of pharmaceutical drug substances and drug products, it is critical that GMPs are closely followed, without exception. For testing of manufactured commercial pharmaceuticals, this includes having validated methods in place. However, for new product discovery, development, and early clinical trial phase work, procedures may not yet be fully developed and/or validated. Much work which goes into procedure exploration follows GLPs but may not be subject to GMP requirements.

If your laboratory has responsibilities for testing GMP products as well as doing GLP work, there may be some distinctions required in order to complete both types of work and remain in compliance. For example, it is perfectly acceptable to use a piece of equipment which is up to GMP standards and meets CFR requirements to do GLP testing. On the other hand, a piece of equipment not meeting CFR requirements may not be used for GMP testing. In addition, test procedures and laboratory paradigms may have differences. It is critical that these lines be drawn in order to stand up to an agency or a client audit.

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