GB/T 38503-2020 in English
VALIDGood manufacturing practice for disinfectant
- Issued on:2020-03-06
- Implemented on:2020-10-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$214.00
| Standard No: | GB/T 38503-2020 |
| Document status: | VALID |
| Title in English: | Good manufacturing practice for disinfectant |
| Title in Chinese: | 消毒剂良好生产规范 |
| Language: | English |
| File Format: | Electronic (PDF) |
| Delivery: | Via email within 1~3 business days |
| Issued on: | 2020-03-06 |
| Implemented on: | 2020-10-01 |
| ICS Classification: | 11.080-Sterilization and disinfection |
| Chinese Classification: | C50-Sanitation in general |
| Professional Classification: | GB-National Standard |
| Related Topics: | disinfectant
Disinfectant en standard Disinfectant en Reagents and production nice letter good Fortunately, the doctor Disinfectant production Class II disinfection products GBT38503 GB/T 38503-2020 industrial disinfectant Can disinfectant products eliminate ointments? Good pastry production General reagent production Defoaming agent production execution Disinfection Technical Specifications Requirements for Disinfection Machines Regulations on non-standard labels for disinfection products gbt38503 |
《GB/T 38503-2020消毒剂良好生产规范》由628（国家疾病预防控制局）归口，主管部门为国家疾病预防控制局。
Introduction
Standard Framework and Technology Evolution
As the first special GMP standard in the field of disinfectant production in my country, this standard integrates the dual requirements of drug GMP and medical device production specifications. Compared with the 2009 version of the "Sanitary Standards for Disinfection Product Manufacturers", 12 new technical chapters such as verification management and critical control points have been added, reflecting the transformation from end-of-line supervision to full-process control.
Comparative Analysis of Core Terms
| Elements | General Disinfectants | Skin and Mucous Membrane Disinfectants |
|---|---|---|
| Production Water | GB5749 Drinking Water | Pharmacopoeia Purified Water Standard |
| Air Cleanliness | General Environment | GB50073-2013 Level 8 |
| Equipment Material | General Material | 316 Stainless Steel, etc. |
Key requirements for factory facilities
Clean workshop design must meet the following requirements:
- Arc-shaped corner treatment of the wall (Clause 5.2.1)
- One-way flow of personnel and logistics (Clause 5.2.2)
- Pressure gradient ≥10Pa (referenced GB50073)
Typical case: A chlorine-containing disinfectant company was ordered to rectify the lack of secondary changing rooms (Clause 5.3.1)
Implementation suggestions
Verification management should focus on:
- The first verification must cover all production links (Clause 9.1.1)
- Major equipment changes require re-verification (Clause 9.1.2)
- Verification is required after resuming production after 6 months of suspension (Clause 9.1.4)
It is recommended to establish a three-dimensional verification system: Installation Qualification (IQ) → Operation Qualification (OQ) → Performance Qualification (PQ)
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