GMP/GDP: When will I be inspected by the Authorities?

Various competent authorities are performing inspections. But who is subject to such an inspection?

http://www.gmp-compliance.org/enews_05297_GMP-GDP-When-will-I-be-inspected-by-the-Authorities_15352,15356,15274,15432,Z-QAMPP_n.html

GMP Inspections are carried out at Manufacturer Licence Holders

A manufacturer of medicinal products must meet Good Manufacturing Practice (GMP) standards. These standards are defined in various laws and regulations. In the EU the compliance with these regulations is checked and assessed by the national competent authorities. The overall goal is to have medicinal products of consistent high quality that meet the requirements of the marketing authorisation (MA) or product specification.

If a company supplies product to the USA, the U.S. Food and Drug Administration (FDA) might inspect the site assuring that drugs, medical devices, certain active pharmaceutical ingredients (APIs) and biological products manufactured in foreign countries and intended for U.S. distribution are in compliance with the applicable U.S. law and regulations.

GDP Inspections are carried out at Wholesale Dealer Licence Holders

Good Distribution Practice (GDP) requires that medicines are obtained from the licensed supply chain and are consistently stored, transported and handled under suitable conditions, as required by the MA or product specification. Many of the actors in the supply chain must implement GDP but are not under supervision. The competent authority for GDP will normally not carry out GDP inspections at transport companies (shipping companies) or at airport hubs.

You will also be inspected when you apply for a manufacturer or wholesaler dealer licence and then periodically, normally based on risk assessments. Overseas manufacturing sites are also inspected when medicinal products or certain APIs are imported to the EU.

Types of inspection

Inspections under a risk-based compliance programme

It is the aim of the competent authorities and inspectorates to prioritise regular inspections based on risk assessments. These inspections are generally announced in advance.

GMP inspections may sometimes be carried out with other inspections, such as with GDP, Good Clinical Practice (GCP) or Good Pharmacovigilance Practice (GPvP).

Product-related GMP inspections

Inspectorates may conduct product-related GMP inspections when assessing an application for a marketing authorisation. This inspection checks if the manufacturer complies with GMP. FDA may also carry out these pre-approval inspections. These inspections are generally announced in advance.

Product-related inspections can also be requested by the European Medicines Agency (EMA) for example by the Committee for Human Medicinal products (CHMp) during the pre-application of a centralised marketing authorisation application or the Co-ordination group for Mutual Recognition and Decentralised Procedures – human (CMDh). EMA uses inspectors from EU member states to ensure compliance with GMP principles.

Triggered or For Cause Inspections

Competent Authorities may inspect you if they are informed about possible GMP or GDP breaches for example by a whistle blower, the press/ media or another regulatory authority.

Here, only little or no notification of these inspections is given in advance.

///GMP inspections, Manufacturer Licence Holders

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Author: DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 30 year tenure till date Dec 2017, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 50 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 19 lakh plus views on New Drug Approvals Blog in 216 countries......http://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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