T/CNPPA 3020-2022 Active Group standards

T/CNPPA 3020-2022 Single Dose Oral Liquid Pharmaceuticals: Guideline for Selecting Composite Film/Bag

Publish Date: 2022-05-09 Implement Date: 2022-05-09 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CNPPA 3020-2022

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Medical materials

Publish Date: 2022-05-09

Implement Date: 2022-05-09

Scope

Main technical content: Oral liquid preparations include oral solutions, oral suspensions, oral emulsions, syrups, compound preparations, and alcoholic preparations. Common packaging for oral liquid preparations includes glass bottles, plastic bottles, composite hard films, and composite films/bags. Oral liquid preparations are packaged according to the dosage form, which can be divided into multi-dose and single-dose packaging. Composite films/bags are commonly used for single-dose packaging of oral liquid preparations. The size of single-dose packaging is generally no larger than 30 mL. Based on the characteristics of oral liquid preparations and packaging requirements, different structurally composed composite films/bags or other packaging forms can be selected. This document considers that conventional oral liquid preparations are not high-risk in terms of administration route, but there is a high possibility of interaction between the preparation and packaging components. Single-dose oral liquid preparations in composite films/bags have the characteristics of accurate dosage, the possibility of not adding bacteriostatic agents to the preparation formula, low risk of contamination during use, easy portability, convenient storage and transportation, and easy opening. Composite films/bags are often pre-printed to reduce the risk of migration of adhesives from conventional external labels. The selection of composite films/bags for single-dose oral liquid preparations should be based on the concept of risk management and sound scientific principles, and the necessary research content, test methods, and quality acceptance standards should be determined based on each structural and compositional composite film/bag and the drug preparation it is intended to package, ensuring the stability and uniformity of batches of composite films/bags. This document does not provide specific test methods and quality acceptance standards, nor does it provide a summary of tests. These