Our Services
Adherence to Good Manufacturing Practice requirements (GMPs) is of fundamental importance for the pharmaceutical industry. GMP requires that manufacturers or distributors operating in domestic or international markets run an adequate Quality System for the manufacture, testing, packaging, labelling, storage and distribution of medicinal products in place. A Qualified Person is required for the quality oversight and release of your products to the European market.
This system should ensure that the drug products are adequately safe and effective for their intended use and meet the required quality and purity characteristics.
We support you to establish these requirements in a way that fits with your company’s needs.
We guide you in setting up an efficient Quality System, support training of your personnel and provide advice for and support you with the preparation, conduct and follow-up of audits and inspections.
Contact us to learn how we can help you find your individual solution.
Our GMP services include:
- Planning and installation of Quality Systems
- Integration of Quality Systems after (or in planning of) mergers and acquisitions
- Review and optimization of existing Quality systems (e.g. to combine ISO and GMP into one QMS)
- Development of Standard Operating Procedures (SOPs)
- GAP analysis
- Risk analysis and risk management
- Investigation support and development of deviation reports
- Planning and conduct of mock-inspections and preparation of inspection reports
- Preparation for regulatory inspections (FDA, EU)
- Preparation, establishmnet and conduct of Quality Management for Contract manufacturing services
- Preparation and review of GMP agreements
- Compliance checks
- Kaizen workshops, Process redesign
- GMP training
Further Services:
Qualified Person
We take on responsibility as Qualified Person acc to Directive 2001/83/EG. QProgress provides experienced Qualified Persons to support your company, i.e. in case of sickness absences or to bridge personnel changes.
Auditing
Global regulatory agencies require manufacturers to conduct audits of suppliers and contract manufacturers to verify the suitability of their quality management systems (QMS).
As certified GMP Auditors, we can help ease the burden on the quality team especially for those companies with numerous API suppliers by providing additional resources to manage the supplier audit programme.
We offer a wide range of internal and external Good Manufacturing Practice (GMP) compliance audit services, including:
- Client site pre-inspection audits
- On site support during regulatory inspections (German and/or English)
- Client site open-book audits to confirm GMP standards
- Pre-selection contractor audits on behalf of a client
- Routine review audits of existing contractors
- Supplier audits plus API, excipient and packing component audits
- For cause CAPA audits
Our auditors are highly experienced industry experts who understand processes and the operator perspective. Our auditors go through an intensive auditor training program leading to independent certification as pharmaceutical auditors.
Translation Services
In an increasingly international environment, translation of local languages becomes more and more important for a successful Quality management.
Based on more than 20 years of professional experience in writing and translation of texts (German-English, English-German), we can offer you valuable support:
- Translation of documents (SOPs, inspection reports or replies, status reports)
- Bilingual documents
- Inspection support (translation, protocols)
- Moderation of teams (English, German, bilingual)
Send an email with your needs and we will contact you to find the best solution for your company.