GMP & GDP Audit Services

PCS can perform GMP and GDP audits of your suppliers worldwide. With our team of experienced auditors we can be efficient, cost-effective and are familiar with any regulatory body and its requirements.

API GMP Audits

GMP requires suppliers of API's (Active Pharmaceutical Ingredients) to be audited by their client. Since 90% of all API's are sourced from India and China, auditing in these countries can be challenging. Regulatory authorities do not consider ISO, GMP or other certificates to be sufficient proof of quality, as such you are required to perform an audit regularly.

Excipient GMP Audits

GMP requires you to only use suitable excipients. These excipients must meet the latest IPEC regulations. Most manufacturers of excipients have a ISO 9001 Quality System and require special care when auditing. PCS has experts which are familiar with the requirements for excipients and can perform expert audits of these suppliers.

Previous Audits

These suppliers have been audited by PCS in the past (not limited to).

*the names of these companies are not kept up to date and may not represent the current situation.

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)

GMP Audits, GDP Audits, GLP Audits and More.

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.

GMP audits of suppliers are an essential tool in supply chain control and many companies currently face the challenge of managing an increasingly extensive and demanding audit program, while keeping the cost under control. This requires an efficient approach to the program and the input of experienced and knowledgeable GMP auditors. View our team of experienced auditors.


Our Audit Services

Pharmaceutical companies are facing an ever-increasing amount of regulatory pressure from the US-FDA, EMA, WHO and other national regulatory authorities. These regulatory authorities regularly conduct inspections that can lead to a halt in many areas such as production. We believe in preventative measures that can save your company painful GMP repair projects and as a result: save time while you maintain focus on revenues, rather than crisis-management.

Click here to contact us if the service you require is not listed below.

Supplier Audits

  • GMP API Audit
  • GMP Excipient Audit
  • GDP Audit
  • Finished Product Audit
  • Mock Audit

Pre-Inspection (GAP) Audits

  • EMA Pre-Inspection Audit
  • FDA Pre-Inspection Audit
  • WHO Pre-Qualification Audit

Own Rules

Own Requirements

A further advantage of our GMP auditing services are that our methodology, reporting and timeline can be adapted to suit the specific needs of your company. This way PCS can ensure that all auditing activities are in full accordance with the client's wishes and requirements.

If a larger number of companies (suppliers) need to be audited, it can be financially advantageous to have PCS perform the planning, communication, auditing and reporting.


Our Advantages

Global Experience

We have already delivered an impressive amount of audits and assessments for companies around the globe.

Broad Knowledge

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

Seasoned Auditors

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

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