Case Histories Failurein cGMP Compliance - Medical device

1 Continuous Regulatory Education program: Perfect Consultants Pvt. Ltd, Pune, India case HISTORY: FAILURES IN cgmp Compliance . Mr. Gupta (M. Pharm.), is a free lancer consultant for US DMF, COS, ANDA, ACTD, CTD, eCTD and other regulatory submissions. He is associated with Perfect Pharmaceutical Consultants Pvt. Limited and Global Institute of Regulatory affairs (Pune, India). The readers are invited to post their queries at Introduction: GMP is a very delicate issue. It looks simple but it is very difficult to practice successfully. Every body knows rules of GMP but very few are successful in interpreting the same precisely.

2 GMP is a system to avoid errors through systematic functions. GMP does need ample of money as good things do not come free or cheap. Further, it also requires high degree of scientific knowledge, skill and expertise. GMP projects are difficult and challenging. However, at the same time they are rewarding and interesting. You must achieve GMP for your company. Followings are the eight most common mistakes resulting in failures in cgmp . Compliance : 1 Mistake:1 Failure to Employ properly qualified, experienced and trained people 2 Mistake:2 Failure to Maintain adequate funds for GMP infrastructure 3 Mistake:3 Failure to Devote sufficient time to manage GMP.

3 4 Mistake:4 Failure to Solicit support from consultants and regulatory bodies. 5 Mistake:5 Failure to Maintain constant vigilance on GMP. 6 Mistake:6 Missing Useful associations 7 Mistake:7 Failure in Time Management 8 Mistake:8 Failure in Designing and Maintenance of facilities MISTAKE: 1. FAILURE TO EMPLOY PROPERLY QUALIFIED, EXPERIENCED AND. TRAINED PEOPLE. cgmp Compliance requires that the key people shall be appropriately qualified and experienced with respect to the products manufactured at the site. Ensure that the people have: 1 Appropriate Qualification and at least 3-4 years experience in required product line.

4 2 High relevancy of the experience with job profile. 3 High IQ and Vigilance for cgmp . 4 Basic understanding of the scientific principles involved in GMP. Copyright Perfect Pharmaceutical Consultants Pvt. Limited, August 2012. All rights reserved. Continuous Regulatory Education program: Perfect Consultants Pvt. Ltd, Pune, India Followings are few case Histories of erroneous appointments of key personnel case History 1: Failure to appoint proper candidate as QC In charge Company Bulk Drug unit at Nashik Candidate Doctorate in Biochemistry.

5 No apparent experience and knowledge of Pharmaceuticals. No much awareness on method validation, impurity profiling and HPLC operations. Appointment as QC In charge Problem The person was effective in conducting day today analysis. Encountered However, he miserably failed in resolving complaints regarding stability, forced degradation and bioburden. He could not achieve standardization of the products with alternative methods. He failed in organizing drug master files. case History2: Company Reputed Pvt. Ltd. company in UP. Candidate , Lead auditor for ISO 9000 Compliance Appointment as QC / QA In charge Problem No problem in day today QC work.

6 However, he could not Encountered match documentation with cgmp Norms and the company failed repeatedly and bitterly during cgmp audits case History 3: Company Bulk Drug Unit in Mumbai Candidate 10 Years experience in Banking (Female). Appointment as Director Technical Operations Problem The lady was very dynamic. Encountered She upgraded the plant in consultation with experts in GMP. However, she failed in total GMP Compliance . She had no adequate knowledge of pest control, bioburden, documentation and method validation. The GMP experts had guided her in this area but she was unable to understand the underneath objective and could not perform well Copyright Perfect Pharmaceutical Consultants Pvt.

7 Limited, August 2012. All rights reserved. Continuous Regulatory Education program: Perfect Consultants Pvt. Ltd, Pune, India case History 4: Company Manufacturing new drug formulations at remote site Candidates M. Pharm. (15 Years experience) appointed as Production Manager. B. Com ( 30 years experience) appointed as Project In charge Problem All the GMP proposed by M Pharm. was rejected by Project Encountered Manager. All previously appointed GMP consultants were fired and denominated. The company failed bitterly during WHO audit case History 5.

8 Company Manufacturing pharmaceutical enzymes from Plant Exudates Candidate with 10 Years experience Appointment as Production Manager Problem Continuous strong complaints on heavy fungal contamination in Encountered finished products case History 6: Company Excipients Manufacturing Company Candidate IAS Officer (40 Years of experience ). Appointment as Managing Director Problem MD has no knowledge of Pharma Industry. He considered Encountered Purchasing even USP/BP raw materials as waste of money. He commanded GMP at gunpoint without any formal training and support from Consultants.

9 He could not run the company an inch towards GMP Compliance over 5 years MISTAKE 2: FAILURE TO MAINTAIN ADEQUATE FUNDS FOR GMP. INFRASTRUCTURE. Copyright Perfect Pharmaceutical Consultants Pvt. Limited, August 2012. All rights reserved. Continuous Regulatory Education program: Perfect Consultants Pvt. Ltd, Pune, India Funds are vital part of cgmp Compliance . No money no GMP. No. The most common errors in managing funds for GMP are: 1 No well defined budget 2 Erratic release of funds for GMP. 3 Anger, grief and nervousness on GMP expenses.

10 4 Continuous downward revision of GMP budget Inadequate funds for GMP lead to: 1 Use of lower quality materials 2 Poor maintenance of machines 3 Poor vigilance Followings are few case History of failure in cgmp Compliance due to failure in management of funds for cgmp . case History 1: No funds for buying current edition of Pharmacopoeias Company A Pharmaceutical Company in Delhi Incident Once (in year 2009) I was auditing a company in India. The company was in manufacturing Excipients as per IP/BP/USP standards. When I asked for the current official copies of products being manufactured at the site, just few relevant pages from pharmacopoeias were presented.