A deviation is any unwanted event that differs from the approved processes, procedures, instructions, specifications, or established standards. Deviations can occur during the manufacturing, packing, sampling, and testing of drug products.
1. CFR - Code of Federal Regulations Title 21-FDA
§ 211.192 Production record review.
All drug product production and control records, including those for packaging and labelling, shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. Any unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications shall be thoroughly investigated, whether or not the batch has already been distributed.
2. European Union.
EudraLex Volume 4 EU Chapter 1 Pharmaceutical Quality System
Section 1.8
(vii) Any significant deviations are fully recorded, investigated with the objective of determining the root cause and appropriate corrective and preventive action implemented;
3. USFDA
Q7 Good Manufacturing Practice Guidance for API Guidance for Industry
2. QUALITY MANAGEMENT
2.1 Principles
2.16 Any deviation from established procedures should be documented and explained. Critical deviations should be investigated, and the investigation and its conclusions should be documented.
4. ICHQ7 GMP Guide for API Step 4 version
2. QUALITY MANAGEMENT
2.1 Principles
2.16 Any deviation from established procedures should be documented and explained. Critical deviations should be investigated, and the investigation and its conclusions should be documented.
5. PIC/S PIC/S PE 009-17 (Part II)
2. QUALITY MANAGEMENT
2.1 Principles
2.16 Any deviation from established procedures should be documented and explained. Critical deviations should be investigated, and the investigation and its conclusions should be documented.
6. SCHEDULE M
GMP and Requirements of Premises, Plant and Equipment for Pharmaceutical Products
2. Quality management
2.1 Principles
2.1.7 Any deviation from established procedures shall be documented and explained. Critical deviations shall be investigated, and the investigation and its conclusions shall be documented.
Read also:
- Deviation Handling and Quality Risk Management
- Difference Types of Deviation in Pharmaceutical Industry
Resource Person: Dr. Prasadhi Shiva
