GMP

Adherence to Good Manufacturing Practice requirements (cGMPs) is of utmost importance for pharmaceutical industry, as they produce and test products that are finally given to the patients. GMP requires that domestic or foreign manufacturers have an adequate quality system for the manufacture, testing, packaging, labelling and storage of medicinal products in place. 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.

However, ensuring compliance with GMP requirements is specifically challenging. Your specialists need to set up your manufacturing processes and control procedures in line with the latest prerequisites in order to successfully pass inspections later on and in order to avoid compliance risks. You need to have an SOP-system in place covering all necessary GMP-requirements.

At HORN Pharmaceutical Consulting, we can help you make things happen. We will guide you in setting up efficient Quality Assurance (QA) systems, in training your personnel and in giving you precious advice for the preparation and conduct of inspections.

Services

Our customized GMP services include:
  • Development of Standard Operating Procedures (SOPs)
  • Planning and installation of GMP-compliant QA systems
  • Critical review and optimization of QA systems
    • GAP-analysis
    • Preparation of corrective action plans
  • Development of qualification and validation strategies
    • Validation master plan
    • Qualification of equipment
    • Process validation
    • Method validation
  • Preparation and review of GMP-agreements
  • Planning and conduct of mock-inspections and preparation of inspection reports
  • Development of corrective action plans
    • Based on mock-inspections
    • Based on inspections from Authorities
  • Preparation for inspections from Authorities
    • FDA
    • EMA
    • National Authorities
  • Contract manufacture/Contract laboratories
    • Review of contracts
  • Compliance checks
  • GMP training 
  • Chemical production, i.e. production of Active Pharmaceutical Ingredients (APIs)
  • Pharmaceutical production
  • Storage and labelling

HOTLINE

Phone +49 (0) 7251/305 529
Fax +49 (0) 7251/305 528
Mail

Events

  • 26.-27.02.2019
    Mannheim: GMP-gerechter Prozess-Transfer
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  • 19.-20.03.2019
    Prague: How to write the Quality Part of an IMPD
    More
  • 26.-27.03.2019
    Copenhagen: Handling Changes and Variations
    More
Get all events



News

  • 10.03.2017
    News for the Industry
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  • 26.07.2013
    News on Change Control/Variations:
    More
  • 31.01.2013
    EU: Revised GMP-Annex 2 published - Details defined for biological products including ATMPs
    More
Get all news
EU: New Variation System in force as of Jan 1, 2010. Filing of variations will be faster, easier, and more flexible. Have you considered that your Change Control System needs to be updated accordingly?
EU: Centralised Marketing Authorisation Procedure for ATMPs needed Have you already filed your application? The time clock is ticking. Transitional periods will be over soon.
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