Results
Thirty-three out of 39 PIC/S Participating Authorities responded (85%). Seven out of 9 applicants to PIC/S responded (78%).
The top most frequently cited categories of GMP deficiencies were:
- Documentation—manufacturing (24)
- Design and maintenance of premises (22)
- Documentation—quality systems (elements / procedures) (20)
- Personnel issues—training (19)
- Design and maintenance of equipment (18)
- Cleaning validation (14)
- Process validation (14)
- Product quality review (14)
- Supplier and contractor audit (13)
- Calibration of measuring and test equipment(12)
- Equipment validation (11).
The total number of deficiencies per group of top 10 most frequently cited deficiencies were:
- Production (99, or 24%)
- Quality system (82, or 20%)
- Quality control (59, or 14%)
- Premises and equipment (58, or 14%)
- Validation (52, or 12%)
- Personnel issues (34, or 8%)
- Materials management (29, or 7%)
- Regulatory issues (5, or 1%)
Figure 1: Most severe cited GMP deficiencies.
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The top most severe GMP deficiencies were (see Figure 1):
- Design and maintenance of premises (15)
- Contamination, potential for (chemical, physical, microbial) (12)
- Design and maintenance of equipment (11)
- Sterility assurance (9)
- Batch-release procedures (9)
- Process validation (9)
- Cleaning validation (8)
- Investigation of anomalies (7)
- Documentation—quality systems (elements/procedures) (7)
- Regulatory issues—noncompliance with marketing authorization (5)
- Documentation—manufacturing (5).
Figure 2: Top most severe deficiencies by group.
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The total number of deficiencies per group of the top most severe deficiencies were (see Figure 2):
- Production (44, or 27%)
- Quality system (32, or 20%)
- Premises and equipment (28, or 17%)
- Validation (22, or 14%)
- Quality control (14, or 9%)
- Regulatory issues (9, or 6%)
- Materials management (8, or 5%)
- Personnel issues (5 or 3%).
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