Inside PIC/S: Top GMP Deficiencies - Pharmaceutical Technology

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Inside PIC/S: Top GMP Deficiencies
Comparison of the top GMP deficiencies cited by the PIC/S Participating Authorities.


Pharmaceutical Technology
Volume 36, Issue 4, pp. 135-137

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.
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.
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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