Some thoughts on the principle of sampling packaging materials

Some thoughts on the principle of sampling packaging materials packaging materials some thoughts on the principle of sampling

article 222 is a new version of GMP inspection sampling operation specification requirements for the material, which make clear a regulation to the sampling procedures should be the enterprise sampling quantity, sampling methods should be scientific, reasonable, to ensure the representativeness of the sample. The representation of the

how to ensure the sample? For medicinal materials and Chinese medicines sliced and prepared for decoction, most of the sampling principles stipulated by the general principles of the pharmacopoeia. Raw material sampling and is generally taken within three pieces, one by one sampling; More than 3 pieces, according to the quantity of total root of 1 sample. But for the packaging materials, how to reasonable sampling, industry practices. Many companies related regulations stipulated by the sampling number proportion and raw materials are the same, but the actual operation is not according to regulations. To this, the author has the following points.

packing material difference

with the essence of raw materials in addition to direct contact with the drug packaging materials and containers, pharmaceutical production enterprise to use the vast majority of packaging materials and drug no direct relationship between the inner quality. Pharmacopoeia guidelines related to the concept of 'medicine packaging material', is refers to 'direct contact with the drug packaging materials and containers', and other packaging materials do not contain among them.

even if direct contact with pharmaceuticals packaging materials, given its in product development phase, has its security, stability, functional, protective and the compatibility with the drug packaging and so on has carried on the comprehensive and systematic research, therefore, under the condition of without changing materials and suppliers, packaging material, on the whole, will not bring big impact on product safety.

as a result, the sampling principle of packaging material is unfavorable to use general raw materials, is neither necessary, also exist in the practical work of interoperability is not strong. Some enterprises not according to procedures stipulated number of label material sampling, in the process of certification examination, be filed as defect project. As a pharmaceutical production enterprise, therefore, it is necessary according to the specific circumstances, to study and formulate sampling principle is different from the raw materials of packing materials.

reasonable classification

of packaging materials for enterprise use all kinds of packaging material, it is necessary according to the quality of drug safety, the possible impact to a reasonable classification.

the author thinks that, to the packaging materials, can also according to the degree of impact on drug quality and safety, is divided into A, B, C three categories.

class A is the packaging materials and containers of direct contact with drugs, including infusion bag ( Bottle, membrane and accessories) , ampoule, medicinal rubber plug, medicinal eye drops ( Nose, ear) Bottle agent, medicinal plate, medicinal aluminum foil, medicinal ointment tube ( Box) And medicinal spray pump ( Valves, cans, barrels, etc. ) , medicinal desiccant, oral preparation filling bottles, etc.

B class packaging materials including all kinds of printed packaging materials ( Such as label, instruction, and printed with product information, packaging materials, etc. ) 。

C packaging material is mainly refers to the printing of no direct contact with the product packaging materials ( Such as envelope, tape, etc. ) 。

according to the classification of packaging materials, and then determine the sampling principle, can meet the requirement of risk management, and can improve the work efficiency, to ensure the implementation of GMP process is practical and effective.

based on the principles of category to determine the sampling

class A packaging material, which is according to the definition of pharmacopoeia 'drug packaging materials', the principle of sampling, Including sampling number of environmental requirements, sampling, etc. ) Should consult relevant raw materials shall be determined. In view of this kind of packaging material may directly affect the product quality and safety, therefore, the enterprise should be in warehouse management, strengthen the sampling process and sample identification process monitoring, ensure that the procedures comply with relevant requirements.

for class B packaging, conformity of the main concern is the printing content. Key program is not the testing samples, and in the previous stages of printing content sample design, proofreading, etc. As for material, etc. , are locked in prior to carry out the printing process. Thus, for a class B material, refer to the quantity of raw materials sampling proportion testing seems not necessary. The author thinks, this kind of material of each lot, only need to check the sample content correctly and to the left. Extracting multiple packaging checking, there is no practical significance. If there are one thousand printing mechanism final packing is wrong, will also use link was found to be in the future, not a major quality event.

as for class C packaging material, as long as the incoming acceptance comply with relevant standards can contract, when no more need to extract multiple packaging testing. Conversion table packaging printing knowledge