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

The FDA makes its inspection results available to the public as required by the Freedom of Information Act. However, very rarely are inspection results of European supervisory authorities accessible in any public domain, except for the periodic publication of regulatory and GMP inspection analysis by the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) and the EMA. The Pharmaceutical Inspection Cooperation Scheme (PIC/S) also has never published the inspection findings of its Participating Authorities.

PIC/S develops and promotes harmonized GMP standards and guidance documents; trains competent authorities, in particular inspectors; assesses inspectorates; and facilitates the cooperation and networking for competent authorities and international organizations. PIC/S celebrated its 40th Anniversary in 2011 and currently has 40 members across six continents.

Background

In November 2011, PIC/S held a workshop designed by the South Africa/Medicines Control Council (MCC) on the similarities and differences in the top 10 deficiencies cited by PIC/S members. South Africa MCC was the first African Participating Authority to host a PIC/S seminar. The authors were invited to design, formulate, and conduct the workshop to help share inspectors' experiences and lessons learned. The workshop, part of a larger PIC/S seminar on Good Pharmaceutical Inspection Practices also served to help document the experiences and lessons learned from performing GMP inspections.

Methodology

Before the workshop, a questionnaire was designed and sent through the PIC/S Secretariat to invite all PIC/S Participating Authorities and PIC/S applicants to share inspection data. The questionnaire requested the following information:

  • Top 10 of the most frequently cited categories of GMP deficiencies within a defined period (i.e., the last period for which data was available). Participants were asked not to differentiate between critical, major, and other deficiencies. Participants also were asked to add for each category the percentage related to the total number of deficiencies in the period under consideration.
  • The top 5 of the most severe GMP deficiencies (critical and/or major) within a defined period.

The scope of the survey was defined for GMP inspection findings of finished product dosage form manufacturers, including medicines for veterinary use and investigational medicinal products, where applicable. Inspections of API manufacturers were out of the scope of this survey.

Because PIC/S does not have a formal list of categories for GMP deficiencies, the UK's MHRA model was used as a standard template. The template was provided with the questionnaire to the participants. A total of 56 categories of deficiencies were defined and divided into 8 groups. However, flexibilities were given to PIC/S Participating Authorities and applicants which might wish to use their own model of deficiency categories.


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