Some Considerations on Sampling Principles of Packaging Materials

[China Packaging Network News] Article 222 of the new version of GMP is a specification requirement for material inspection and sampling operations, which clearly specifies that sampling procedures should be specified by the sampling operation procedures established by the company. The sampling method should be scientific and reasonable to ensure the representativeness of the samples.

How to ensure the representativeness of sampling? For herbal medicines and traditional Chinese medicines, most of the sampling principles specified in the general pharmacopoeia are used. Sampling of raw materials is generally taken within 3 samples and sampled one by one; more than 3 samples are taken according to the total number of samples plus 1 for sampling. However, for packaging materials, how to sample is more reasonable and the industry practices are not consistent. Many companies' related regulations stipulate the same number of samples as the original materials, but they are not implemented according to the regulations during actual operation. In this regard, the author has the following thoughts.

The essential difference between packaging materials and raw materials

Except for packaging materials and containers that are in direct contact with drugs, the vast majority of packaging materials used by drug manufacturers are not directly related to the intrinsic quality of drugs. In the relevant pharmacopoeia guidelines, the concept of “medicine packs” refers to “packaging materials and containers that come in direct contact with medicines”. Other packs do not include them.

Even packaging materials that are in direct contact with pharmaceuticals have undergone a comprehensive and systematic study of their safety, stability, functionality, protection, and compatibility with the packaged drugs, given their product development stage. Without changing the materials and suppliers, packaging materials will not have a major impact on product safety.

Therefore, the sampling principle of packaging materials should not be applied to the general raw materials. It is neither necessary nor practical. Some companies did not sample the label packaging materials according to the number of regulations, and were submitted as defective items during the certification inspection process. Therefore, as a pharmaceutical production enterprise, it is necessary to study and formulate sampling principles for packaging materials that are different from the original materials according to specific conditions.

Reasonable classification of packaging materials

For various types of packaging materials used by enterprises, it is necessary to rationally classify them based on their possible impact on the safety and quality of drugs.

The author believes that the packaging materials can also be divided into three categories: A, B, and C according to their impact on the quality and safety of pharmaceuticals.

Category A refers to packaging materials and containers that are in direct contact with drugs, including infusion bags (bottles, films and accessories), ampoules, medical rubber stoppers, pharmaceutical eye drops (nasal, ear) bottles, medical rigid tablets, and pharmaceuticals. Aluminum foil, medicinal ointment tubes (boxes), medicinal spray pumps (valves, cans, barrels, etc.), pharmaceutical desiccants, and oral preparation filling bottles.

Class B packaging materials include various kinds of printed packaging materials (such as labels, instructions, and packaging materials with product information).

Class C packaging refers mainly to non-printing packaging materials that do not directly contact the product (such as packaging films, tapes, etc.).

According to the classification of packaging materials, and then determine the sampling principle, it can not only reflect the risk management requirements, but also improve work efficiency and ensure the pragmatic and effective implementation of the GMP process.

Determine the sampling principle according to the category

A type packaging materials, that is, the "pharmaceutical packaging materials" defined in the pharmacopoeia, the sampling principle (including sampling the number of sampling, sampling environmental requirements, etc.) should be determined with reference to the relevant provisions of the original excipients. Since such package materials may directly affect the product quality and safety, enterprises should strengthen monitoring in the whole process of warehouse management, sampling process, sampling identification, etc. to ensure compliance with relevant regulations.

For Class B packaging, the main concern is the compliance of printed content. The key procedure does not lie in sampling and testing, but in the previous stage of designing and proofreading proofs of printed content. As for materials, etc., they are all locked in the early implementation of the printing process. Therefore, for Class B packaging materials, it may not be necessary to test the sampling ratio of the number of raw and auxiliary materials. The author believes that for each batch of such materials, only the contents of the proofs need to be verified and stored. Extracting multiple package inspections has no practical significance. If there is an error in the final packaging of a printing organization, it will be discovered in the future use and will not lead to significant quality events.

As for the C-type packaging materials, as long as the acceptance of the inspection meets the relevant contract standards, there is no need to extract multiple packaging inspections.