GxP Audit Services
Audits of CMO's, excipients, API's, intermediates and service providers
PCS has 29 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):
- CMO's (Contract Manufacturing Organization)
- API and excipient suppliers
- Distribution and warehousing organizations
- Service providers
- Contract laboratories
- Your own organization (mock audit/self-inspection)
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 preparation
- Audit execution
- Audit reporting
- CAPA review (optional)
- CAPA recommendation (optional)
- CAPA implementation (optional)
Using our extensive experience PCS can take ownership of your entire audit program. Our services include:
- Inventory of suppliers/contractors
- Risk assessment and audit focus
- Audit planning
- Audit execution
- Recommendations on supplier/contractor suitability
- CAPA review and follow-up
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
- Serum Institute of India (Pune). Support in the design and construction and implementation of quality systems for three new buildings including two vaccines and one sterile finished dosage form. FDA approved.
- Assistance in start-up and quality systems for Protein Sciences (Meriden U.S.). FDA approved.
- Long-term support for Boehringer Ingelheim IT, (Biberach, Germany). FDA approved.
- Long-Term QA support for Roche (Mannheim, Germany). FDA approved.
- WHO Prequalification audit and support for Yuxi Walvax (China).
- Acambis (Cambridge U.S.) QA support in startup and operation of a vaccine manufacturing plant. FDA approved.
- Genibet (Lisbon, Portugal). Design Qualification of a Biotech Manufacturing facility and QA support to Licensing. EU approved.
Our consultants have performed a significant number of assignments globally, in a range of different industries.
We are a dedicated team of consultants who know all ins and outs of Quality Systems and its potential issues.
Our consultants work in a great number of companies across the pharmaceutical industry as Subject Matter Experts.
Overview of Our Services
Click here to contact us if the service you require is not listed below.
- GAP Analysis and Benchmarking
- Risk Assessments of (Proposed) QA Systems
- Development of Pharmaceutical Quality Systems & Quality Culture
- Definition of Suitable Metrics for Quality Monitoring and Improvement
- Practical Implementation Support of Entire Quality Systems or parts thereof
- Coaching and training of personnel at all levels within the organization in the principles and practice of Quality Systems
- Independent inspections to determine ongoing compliance to in-house, corporate or official Quality System requirements
- United States Food and Drug Administration (FDA)
- European Medicines Agency (EMA)
- World Health Organization (WHO) Qualification
- World Health Organization (WHO) Pre-Qualification
- Russian Good Manufacturing Practices (SID & GP)
- Indian National Regulatory Authority (NRA)
- Other National Regulatory Authorities