CGMP stability requirements

Biobatch manufacturing Inspection to determine the establishment s compliance with cGMP requirements, including a data audit of the specific batches on which the application is based (e.g., pivotal clinical, bioavailability, bioequivalence, and stability) is a field office responsibility. CDER scientists are responsible for the review and evaluation of the records and data submitted in the application, including the components, composition, batch instructions, in-process and finished product test points, and... 

Product stability Inspection of the establishment to determine compliance with cGMP requirements and to conduct an audit of the data furnished to CDER in the application is a Field responsibility. This requirement applies to both the relevant preapproval batches, as discussed above, and the proposed commercial batches. CDER application review chemists are responsible for review of the proposed drug product stability protocol, specifications, and evaluation of the data submitted in support of the expira-... 

In this guidance the FDA offers some direction for the demonstration of comparability. They request that the manufacturer provide evidence that the methods, facilities, and controls that were used to manufacture previous products conformed to cGMPs and to other applicable regulatory requirements. In addition they request the submission of validation summaries, as well as product characteristics such as total nucleated cell count, viable CD34 cell count, and number of colony-forming units. Stability data and information from the scientific literature can also be used. Clinical outcomes can be part of the comparability demonstration. 

The cGMP requirements of a stability program reside in 21CFR Part 211.166. Table 2.1 lists a summary of components needed to support a stability testing program for pharmaceutical products. 

Section 211.194 details how the testing results are to be documented and the testing methods validated. These criteria also apply to the testing procedures used to perform stability testing, as well as release testing. Table 2.2 lists the requirements of laboratory records specified in this cGMP section. Drug products are only to be released if the test results conform to pre-determined acceptance criteria. 

Stability data evaluation must begin when raw data is generated in the laboratory. cGMPs require that drug products and drug substances must meet their... 

Chapter 2 introduces the critical current Good Manufacturing Practices (cGMP) regulations that are applicable to a stability program. It describes different types of stability studies to support the drug development process and discusses the GMP requirements surrounding the stability sciences. 

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