The production process of the pharmaceutical workshop can be divided into the following core links, which need to be strictly managed based on the characteristics of different dosage forms and GMP standards. Bo Tai editor will take you to understand the relevant knowledge.

1、 Material Management and Quality Control

1. Quality Control System

Process monitoring, real-time monitoring of key parameters, and sampling and testing of intermediates.

2. Raw material acceptance and storage

Before storage, complete physical and chemical properties, microbial limits, and other inspections, and store them in a temperature and humidity controlled warehouse by category.

3. Supplier confirmation and procurement

Select designated suppliers and pass qualification audits to ensure that raw materials meet pharmacopoeia standards. Implement quality agreement signing and transportation condition monitoring in the procurement process.

2、 Clean area management

1. Execute the three-level changing procedure: First shift → Second shift → Hand disinfection → Airlock buffering.

2. Pressure difference control: clean area>adjacent area 5Pa, clean area>external 10Pa.

3、 Packaging and Storage

The inner packaging aluminum-plastic blister packaging machine and automatic boxing machine complete the primary sealing. The electronic supervision code traceability system is associated with batch production records, and the elevated warehouse uses an automatic conveyor chain to achieve zero manual contact storage.

4、 Special Process Support System

Purified water system: raw water → multi-media filtration → reverse osmosis → EDI → distribution circulation. ‌

Air conditioning purification system: High efficiency three-stage filtration for junior high school students, with a ventilation rate of ≥ 20 times/hour.