The PDA Europe - PIC/S Workshop from May 9-10, 2012 in Geneva, was a big success for all the 180 participants coming from 45 countries. The debates were highly interesting and the workshops were booked out.
Boon Meow Hoe (HAS, Singapore Agency) and Hans Smallenbroek (IGZ, Netherlands Agency) opened the event by presenting the very interesting results of a PIC/S internal survey on GMP deficiencies. 39 PIC/S member agencies and 9 PIC/S applicants answered a questionnaire about the
- Top ten of the most frequent cited categories of GMP deficiencies and the
- Top five of the most severe GMP deficiencies (critical and/or major).
Only eight agencies did not answer to the questionnaire at all. Overall this can be considered as a great success and a valuable database for the conclusions below.
The questionnaire was limited to finished dosage forms only (human, veterinary, investigational products) and not for APIs. The deficiencies are based on a MHRA-list of 53 common deficiencies in the eight areas of:
- Quality System
- Personal Issues
- Premises and Equipment
- Quality Control
- Validation
- Production
- Material Management
- Regulatory Issues
Top 10 of most frequent categories
The top 10 most frequently cited categories of GMP deficiencies are (number of citations in brackets):
Rank 1 Documentation – manufacturing (24)
Rank 2 Design and maintenance of premises (22)
Rank 3 Documentation - quality system elements/procedures (20)
Rank 4 Personnel issues – training (19)
Rank 5 Design and maintenance of equipment (18)
Rank 6 Cleaning validation (14)
Rank 6 Process validation (14)
Rank 6 Product Quality Review (14)
Rank 7 Supplier and contractor audit (13)
Rank 8 Calibration of measuring & test equipment (12)
Rank 9 Equipment validation (11)
Top 10 of most severe GMP deficiencies
The top 5 most severe GMP deficiencies are (number of citations in brackets):
Rank 1 Design and maintenance of premises (15)
Rank 2 Contamination (chemical, physical, microbial) (12)
Rank 3 Design and maintenance of equipment (11)
Rank 4 Sterility assurance (9)
Rank 4 Batch release procedures (9)
Rank 4 Process validation (9)
Rank 5 Cleaning validation (8)
Rank 6 Investigation of anomalies (7)
Rank 6 Documentation - quality system elements/procedures (7)
Rank 7 Regulatory issues - non-compliance with marketing authorisation (5)
Rank 7 Documentation – manufacturing (5)
The most frequent deficiencies were also evaluated by groups. Production and quality system turned out to be the two groups most cited.
In summary these are:
Ranking | Most frequent deficiencies | Most severe deficiencies |
Rank 1 | Production (99 citations, 24%) | Production (44, 27%) |
Rank 2 | Quality system (82, 20%) | Quality system (32, 20%) |
Rank 3 | Quality control (59, 14%) | Premises and equipment (28, 17%) |
Rank 4 | Premises and equipment (58, 14%) | Validation (22, 14%) |
Rank 5 | Validation (52, 12%) | Quality control (14, 9%) |
Rank 6 | Personnel issues (34, 8%) | Regulatory issues (9, 6%) |
Rank 7 | Material management (29, 7%) | Material management (8, 5%) |
Rank 8 | Regulatory issues (5, 1%) | Personal issues (5, 3%) |
As can be clearly seen the most frequent deficiencies are also the most severe deficiencies, except for the two categories quality control and regulatory issues.
Observations
PIC/S observed that different participating authorities used different classification models for identifying GMP deficiencies. Also different levels of details of the deficiency classes were observed. This makes a comparison sometimes difficult. On the other hand there are no significant differences among the regions and there are close correlations between the most frequent and the most severe GMP deficiency classes.
„The 10 most frequently cited GMP deficiency classes show that the industry is weak in these areas and inspectors should communicate more effectively and efficiently with the industry on such weaknesses.“
It may be easy to detect e.g. documentation issues in manufacturing, which ranks as #1 deficiency while the #2 deficiency „design and maintenance of premises“ may be related to aged buildings or saving on maintenance budget. But every company has to draw its own conclusions on these observations.
Recommendations
It was recommended that all PIC/S Participating Authorities (PA) should conduct GMP deficiency analysis and trending within defined periods (e.g. annually). This would help to identify trends across different years. Therefore, a GMP deficiencies classification model may be required that would be accepted by most PIC/S PAs.
It was also a common sense that it may be useful to adopt such an analysis at PIC/S level on an annual basis. The data from each PIC/S PA could be collated for analysis/trending across all PIC/S PAs and applicants. This collated output may also be used as a training need analysis to identify common specific GMP areas to be focused on training and to pull all resources together within PIC/S.
Conclusion
The presentation of the survey was a good starting point for the discussions in the following two workshop days and interactive discussions. As a summary I noticed very open contributions from industry and authorities. Nobody hesitated to represent a different point of view or to comment on somebodies opinion.
Over the last twenty years I never visited an event so open minded between industry and authorities. It would certainly be a good step forward to see more such events.
A very important conclusion of the survey is that there already is a harmonisation of inspections across all PIC/S Participating Authorities. PIC/S can be proud to see this as a result of the long term engagement in GMP inspection harmonisation. I have no doubt that PIC/S will also play an important role in the further harmonisation of global GMPs.
GMP cGMP (current Good Manufacturing Practice):
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