GMP-GDP Audit of Pharma CMO, API, Excipient, Finished Product and Intermediates

GxP AUDITS

PCS can perform GMP, GLP and GDP audits of your API or Excipient Supplier/CMO/Intermediates or Services Providers worldwide. With our team of experienced auditors we can be efficient, cost-effective and are familiar with any regulatory body and its requirements.

GxP Audit Services

Audits of CMO's, excipients, API's, intermediates and service providers

Audit Experience

PCS has 28 years of experience in auditing suppliers and contractors in GMP and GDP. Between 2010 and 2012 we conducted all supplier audits for Sandoz International and Novartis. The total amount of audits conducted by PCS exceeds 600. With this extensive experience we can perform entire audit programs of suppliers and contractors.

Who Can We Audit?

PCS can audit the following types of supplier and contractors (amongst others):

Services

PCS prepares, performs and reports the audit directly to the client. The focus of the audit is determined by the client and can include (for example); due-diligence, for-cause, following a complaint, routine, self-inspection, etc. If desirable, PCS can recommend and review CAPA's following an audit.

Audit Programs

Using our extensive experience PCS can take ownership of your entire audit program. Our services include:

For more information about our audits, contact us.

Recent GMP-GDP Audits

PCS has conducted numerous audits over the years, an excerpt of the audits we have conducted in recent years may be found below:

ACS Dobfar (Italy), Amino Chemicals (Malta), AMSA (Italy), Bayer (Germany), BeltaFarm (Italy), Biomendi (Spain), Bionorica (Spain), Cambrex (Italy), CKD Bio (South-Korea), Delpharm (France), Dionex Softrom (Germany), Divis (India), DMV-Fonterra Excipients (the Netherlands), Dr Reddy's Laboratories (India), Kyowa Hakko (Japan), Indena (France), Euromed (Spain), Lab Analysis (Italy), Lusochimica (Italy), Medispray (India), Meditop (Hungary), Medpro (Latvia), Merck Spittal (Austria), Mibe (Germany), Natco (India), Nobilus Kutno (Poland), NTC (Italy), Pharmazell (India), Rohm und Hass (France), Salus Haus (Germany), Sanofi Aventis (France), Shilpa (India), Sicor (Italy), SIMS (Italy), SMB (Belgium), Solmag (Italy), Special Products L (Italy), Swisscaps (Switzerland), Synthon (the Netherlands), TEVA Bulciago (Italy), TEVA Settimo (Italy), Unichem Labs (India), Union Quimico (Spain), Weimer (Germany), Zhejiang Cheng Yi (China), Zhejiang Gold Ph (China), Almac (Ireland), Areta (Italy), Dompe (Italy), Astral (India), Chemagis (Israel), Chirogate (Taiwan), Claris Life Sciences (India), Daito Corporation (Japan), Dipharma Francis (Italy), Ebewe (Austria), Eskayef (Bangladesh), GSK Barnard Castle (United Kingdom), Hetero (India), Impstoffwerk Dessa-Tornau (Germany), Kyung Dong Farma (South-Korea), MacFarlan Smith (United Kingdom), Oman Pharma (Oman), Qilu (China), Ranbaxy Laboratories (India), Scanfarm (Denmark), Scherer (Germany), SoluPharm (Germany), Sri Krishna Pharmaceuticals (India), TTY Biopharm (Taiwan), Weimer Pharma (Germany), Statens Serum Institute (Denmark), Fresenius (Germany), Nerpharma (Italy), Aarti (India), Abic (Isreal), ACS Dobfar (Italy), Allergan (Ireland), Amoli Organic (India), Assia (Israel), Actavis (Bulgaria), BASF Ludwigshaven (Germany), BASF Minden (Germany), Buchler (Germany), Centaur Chemicals (India), Centifarm (France), Chanelle (Ireland), Changzhou Pharmaceuticals (China), Chemi SpA (Italy), Chong Kun Dong (Macau), Corden Pharma (Italy), Daiwa (Japan), Diaco (Italy), DiPharma Francis (Italy), Dishman (the Netherlands), Disphar (the Netherlands), Dong Kook Pharma (South-Korea), DSM St. Perpetua (Spain), Egis (Hungary), Elaiapharm (France), Emcure Pharmaceuticals (India), Erregirere (Italy), Evonik (United States), Farmbios (Italy), Fidia (Italy), Glenmark (India), Granules (India), HEC Biochem (China), Hovione (Macau), IchTJ (Poland), TriPharma (Italy), IPCA (India), Kaifeng Hengyu Ph (China), Katwijk Chemie (the Netherlands), Kern Pharma (Spain), Kilitch (India), Laboratorio Farmaceutico (Italy), Laboratorios Leon (Spain), Landen (Belgium), Matrix Labs Unit Eight (India), Megafine (India), Merckle (Germany), Neuland Labs (India), NIPRO (Japan), Orchid (India), PCAS (France), Pharco B (Egypt), Pharco Pharmaceuticals (Egypt), Plantex (Israel), Poli Industries (Italy), RL Fine Chemicals (India), Rotexmedica (Germany), Sanochemia (Austria), Sanofi Aventis (Bangladesh), Shandong (China), Shanghai Harvest (China), Siegfried (United States), SigmaTec (Egypt), GlaxoSmithKline (Egypt), Symed (India), Tianjin Jinjin (China), Vifor (Switzerland), Xelia (Norway), Xelia (Budapest), Yonsung Fine Chemicals (South-Korea), Yung Zip Chemical Ind. (Taiwan), Yunnan Hande Bio Tech (China), ZaCH Systems (Italy), Yuxi Walvax (China), Yuxi Shanghai (China), GenIbet (Portugal), Fisher Farma (the Netherlands), Banner Pharmacaps (the Netherlands), Roche (United States), Medinsa (Spain), Fermenta Biotech (India), Imerys Talc SPA (Italy).

PCS does not sell or otherwise provide audit reports to third parties.

"PCS (est. 1990) is your partner for GMP and GDP audits."

GMP qualification (auditing) of manufacturers of active substances is a precondition for approval of dossiers and is a regulatory expectation for batch release of medicinal products.

Proven Track Record

Our Advantages

Global Experience

Our consultants have performed a significant number of assignments globally, in a range of different industries.

Broad Knowledge

We are a dedicated team of consultants who know all ins and outs of Quality Systems and its potential issues.

Seasoned Consultants

Our consultants work in a great number of companies across the pharmaceutical industry as Subject Matter Experts.

Overview of Our Services

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