cGMP and GLP Credentials

    
Since 1983, Quality Quest consultants have worked with speciality chemical, bio-chemical, medical, food and pharmaceutical clients in over 30 different countries to upgrade their ISO.9000 compliant Quality Management Systems to satisfy the relevant requirements of cGMP/GLP, 21 CFR 820, PS.9000 Pharmaceutical Packaging Materials and PS.9100 Pharmaceutical Excipients. All clients who have applied for GMP certification have passed first time using FDA or local national registrars. The following consultancy assignments are typical examples of our experience.

Manufacturer of High Purity Chemicals and Gases for Medical Products, Georgia.
GMP and GLP audits of the Quality Management Systems of the principal manufacturing site of an international client, who were planning major business expansions into higher margin, medical products requiring FDA approvals. Audits included order entry, production planning, purchasing raw materials, process control, QC lab. methods, QA, SPC, validation, calibration, preventive maintenance, labelling, packaging, storage, shipping, dispatch and training procedures. Final report to Corporate QA Director included analysis of strengths and weaknesses, followed by positive recommendations to improve the effectiveness of their GMP Quality Systems, especially to minimise cross-contamination, improve method and equipment validation, enhance labelling systems and implement electronic document control systems.

Pharmaceutical Manufacturer, Portugal.
Assignment involved the documentation and implementation of a Validation Master Plan for a new tablet production facility of the largest privately owned pharmaceutical manufacturer in Portugal. Quality Quest consultants, working in both English and Portuguese, involved the senior management in the development and implementation of the various phases of the Validation Master Plan. This was designed to enable the client to gain the necessary marketing authorisations to sell new pharmaceutical products in Portugal, Spain and other export markets. The scope of the validation program included buildings, equipment, methods, people, products and computers. Internal training was carried out to explain the basic elements of cGMP validation techniques and we carried out Quality Management System assessments, prior to successful certification by third party pharmaceutical assessors.

Speciality Chemical Manufacturer, UK and US.
Design, development and implementation of cGMP and GLP Quality Systems in a major international resins and adhesive business division of a multi-national chemical manufacturer, supplying speciality chemicals to high quality standards to the medical, food, nuclear and pharmaceutical industries. Significant improvements were made to upgrade the existing ISO.9001 Quality Systems to satisfy GMP/GLP requirements, especially in design of processes, validation systems, raw material QC and traceability methods, cleaning and changeover procedures, document control systems and management of change procedures. These improvements to the effectiveness of the Quality Systems in UK and US plants enabled the client to expand sales in profitable, high margin businesses, also resulting in enhanced customer satisfaction and significant reduction of rework.

Spray Drying Company, New Jersey.
Carried out GMP audits on the spray drying units of an ISO.9001 certified client, who wanted to improve process controls for high quality food products and pharmaceutical excipients to satisfy FDA requirements. Reported deficiencies for spray drying food products against FDA cGMP requirements of 21 CFR, Part 110 and gave a series of recommended actions to improve processing procedures to minimise contamination, improve cleaning, method validation, equipment calibration and raw material tractability standards.

Excipients Manufacturer, Chicago, IL
Carried out comprehensive Gap Analysis of the Quality Management Systems of a pharmaceutical excipients manufacturer against the requirements of the intermediate GMP level of PS.9100:2002. Provided the client with a list of 45 recommended actions to improve their existing Quality Systems to comply with PS.9100 requirements, based on ICH Q7A. Agreed a realistic 12 months GMP Implementation Plan with clearly defined timelines, responsibilities for actions and progress reviews. Trained internal auditors to plan, carry out and report the findings of PS.9100:2002 compliance assessments. Carried out product audits and process assessments to regularly monitor the effectiveness of the GMP implementation program. Gave the client detailed recommendations for corrective and preventive actions to further improve their GMP compliance, especially with respect to contamination controls, cleaning protocols, equipment and method validation and raw material traceability.

Packaging Division of Pharmaceutical Manufacturer, UK.
Designed and presented a two-day PS.9000:2001 Pharmaceutical Packaging Materials auditing training course for internal assessors wishing to audit for quality improvement as well as compliance to the relevant cGMP standards based on 21 CFR 820. After one day of teaching the classroom theories and principles of effective auditing, during the second day supervised practical audits of the manufacturing processes by the trainees and gave professional feedback on the performance of the auditors.

Pharmaceutical Drug Manufacturers Six Sigma Workshops, UK and US.
Designed and presented several training seminars to assist pharmaceutical companies to implement Six Sigma quality programs in GMP compliant Quality Management Systems. Provided Six Sigma black belt and green belt training sessions in house to support the achievement of business objectives. The training included "lean sigma" tools and techniques designed to reduce waste and add value, especially to the critical supply chain processes but at the same time maintaining compliance to FDA requirements.

Active Pharmaceutical Ingredient, API, Manufacturer, UK.
Carried out, on behalf of a large international pharmaceutical client, a GMP Gap Analysis against the requirements of ICH Q7A at a subcontract manufacturer in England. Before starting the Gap Analysis, assisted the client to carry out a Risk Assessment to agree the scope and critical elements of the audit based on business as well as technical considerations. Gave the client a comprehensive report listing deficiencies, non-conformances and recommendations for improvement, which was used by the subcontractor as the basis of a GMP Quality Systems Improvement Implementation Plan.