GMP & GDP Consultancy Services for the Pharmaceutical Industry

PCS Provides GMP & GDP Consultancy and Regulatory Compliance Solutions in Pharma

Sterile Production Processes

e.g. Vaccines, OPV, Hormones, Anti-Biotics, Vitamins, Parenteral
PCS has significant practical, theoretical and Regulatory experience in the manufacture of sterile pharmaceutical products. PCS can therefore provide sterile production consultancy advise on; equipment requirements, environmental matters and personnel training needs for this important class of products.
Sterility Testing Media Fills Microbiological Deviations Clean Room Operator Training New Plant Start-Up and Utilities / Equipment

Quality Assurance (QA) Consulting

For GMP & GDP regulated organizations including FDF, Intermediates, API and Excipient Manufacturers
PCS will review, update or advise on QA systems. If necessary, an entire QA concept can be developed; support can be provided for its implementation, maintenance and monitoring. In particular, PCS are able to assist in the preparation of Quality Assurance handbooks which can be either custom-designed or modelled on the requirements of ISO 9000.
Quality Management Systems (QMS) GMP & GDP Training Supplier Qualification Interim Management

Documentation Support

Advice on all Aspects of Control and Manufacturing Documentation
PCS can advise on all aspects of control and manufacturing documentation. This can include the initial planning of a basic documentation system, through to actual preparation of documents required by the client. PCS are able to supervise and subsequently review the translation of any pharmaceutical documentation in English, German, French, Dutch or Spanish. PCS has consultants on staff who can perform documentation review and SOP (procedure) writing with experience in both GDP & GMP Quality Management Systems (QMS).
Documentation/SOP Writing Documentation/SOP Review Documentation/SOP Translation Documentation System Planning

Interim Management

Quality Assurance, QP & RP Services, GMP Upgrade or Repair
PCS has extensive experience in providing interim management and QP services for both multinational and SMB companies, both long term and short term, in various areas of expertise. In addition to these standard services, a network of experienced and reliable associates allows PCS to provide a number of specialised services, which include: business consulting, ICT consulting, in-house translation capabilities in French, German, Dutch, English and Spanish, Interim Management, microbiological services, project management, inspections and preparations to regulatory inspections, research and development.
QP & RP Services GMP Upgrade & Repair Quality Assurance

Self-Inspection & GMP Auditing

Self-Inspection Support and Wordlwide Third-Party Audits
Current GMPs call for a comprehensive programme of self-inspection and auditing as part of the Quality Management system. PCS will carry out such audits against published GMP guidelines, both as part of pre-inspection preparations or as part of the ongoing self-inspection programme. In addition, PCS will carry out third party audits and inspections of suppliers of starting materials or equipment.
Self-Inspection Third Party Audits (GMP & GDP) Third Party Audit Programs

Pharmaceutical Engineering Projects

e.g. Initial Facility Design, Project Consulting, Project Management, Installation & Validation
PCS can provide a full service from initial facility design, through project consulting, project management, installation and validation, all to recognised Regulatory requirements. If called upon, PCS can arrange for the purchase, installation and validation of pharmaceutical equipment.
Facility Design Project Management & Consulting Installation & Validation

Download Our Service Overview

GMP Consultancy Brochure

Use the button below to download our consultancy services overview. A few of our most popular services are included in this brochure. If your service is not listed above or in the brochure please contact PCS

GMP Consultancy Services GMP Interim Management GMP Audits