Pennsylvania Code
Title 28 - HEALTH AND SAFETY
Part III - Prevention of Diseases
Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS
Subchapter A - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS
GOOD MANUFACTURING PRACTICE IN MANUFACTURE, PROCESSING, PACKING OR HOLDING OF DRUGS
Section 25.14 - Components
Current through Register Vol. 54, No. 44, November 2, 2024
Components and other materials used in the manufacture, processing and packaging of drug products, and materials necessary for building and equipment maintenance, upon receipt shall be stored and handled in a safe, sanitary and orderly manner. Adequate measures shall be taken to prevent mixups and cross-contamination affecting drugs and drug products. Components shall be withheld from use until they have been identified, sampled and tested for conformance with established specifications and are released by a materials approval unit. Control of components shall include the following:
(1) Each container of component shall be examined visually for damage or contamination prior to use, including examination for breakage of seals when indicated.
(2) An adequate number of samples shall be taken from a representative number of component containers from each lot and shall be subjected to one or more tests to establish the specific identity.
(3) Representative samples of components liable to contamination with filth, insect infestation, or other extraneous contaminants shall be appropriately examined.
(4) Representative samples of all components intended for use as active ingredients shall be tested to determine their strength in order to assure conformance with appropriate specifications.
(5) Representative samples of components liable to microbiological contamination shall be subjected to microbiological tests prior to use. Such components shall not contain microorganisms that are objectionable in view of their intended use.
(6) Approved components shall be appropriately identified and retested as necessary to assure that they conform to appropriate specifications of identity, strength, quality, and purity at time of use. This requires the following:
(7) Appropriate records shall be maintained, including the following:
(8) An appropriately identified reserve sample of all active ingredients consisting of at least twice the quantity necessary for all required tests, except those for sterility and determination of the presence of pyrogens, shall be retained for at least 2 years after distribution of the last drug lot incorporating the component has been completed or 1 year after the expiration date of this last drug lot, whichever is longer.
This section cited in 28 Pa. Code § 25.19 (relating to laboratory controls).