New GxP facilities, validation, qualification, training and overall GxP adherence
PCS has 30 years of experience in the engineering aspect of the pharmaceutical industry. We have aided in the construction of vaccine, oral solid dosage and biotech manufacturing facilities worldwide. Through our worldwide network we can select the right equipment and contractors. Additionally, PCS can perform the qualification and validation of equipment. Overall GMP and GDP adherence will be ensured, including the set-up of QA and QC departments and the training of staff.
Common Engineering Projects
Below is a list of engineering projects PCS most commonly provides (amongst others):
- New construction of GMP certified factories (green-field)
- Selection of pharmaceutical equipment
- Validation and qualification of new or existing equipment
- Selection of production/QA/QC/cleaning staff
- QC and QA department creation
- Staff training
- Trial runs (media fills)
- GxP inspection preparation and response
PCS is a successful specialist builder of GMP buildings. Buildings for special applications, where people have to work according to the regulations of GMP (Good Manufacturing Practices). Buildings of this kind, such as pharmaceutical production facilities, are subject to complex regulations. These regulations can have far reaching effects, particularly on the materials that can be used, as well as the dimensions, construction and equipment. Even the finish of the building, its ergonomics, the routing of people, goods and products through the building, are effected. This is to prevent undesirable contamination and exchanges. PCS integrates these requirements into the design right from the outset. This avoids costs and production losses later on due to building modifications.
- DQ/IQ/OQ/PQ of facilities
- Material/personnel flow assessment
- Design review
- Creation of documentation
- Validation and qualification of equipment and utilities
- Validation of overall activities
"PCS (est. 1990) is your partner for pharmaceutical engineering projects."
PCS is a successful specialist builder of GMP buildings. Buildings for special applications, where people have to work according to the regulations of GMP (Good Manufacturing Practices). Buildings of this kind, such as pharmaceutical production facilities, are subject to complex regulations.
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
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- 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