QVA AND GMP COMPLIANCE

Pharmaplan was founded more than four decades ago by a pharmaceutical manufacturer – GMP is therefore in our blood and we are happy to share our many years of experience with our customers in the pharmaceutical industry, so that they can meet the constantly growing international quality requirements.

Qualification and Validation

Through close interdisciplinary cooperation with our Pharmaplan experts from project planning, engineering and GMP compliance, we can offer our customers seamless qualification and validation services.

We support our customers in planning, assist in the development of qualification and validation strategies, advise on the current legal guidelines of the various countries and provide a complete documentation package. Our highly qualified employees complete complex workflows in compliance with GMP, even within limited time frames. In this way, we prepare our customers for the start of GMP-compliant production or for upcoming inspections by the authorities.

Our Pharmaplan qualification experts have extensive experience with the quality systems of wellknown pharmaceutical manufacturers, but are of course flexible enough to develop solutions tailored to individual customer needs. In addition, access to the defined Pharmaplan internal quality system, which follows the risk-based approach and the verification model according to ASTME2500, allows processes to be accelerated.

Our specialists in the QVA area are competent contact persons for these areas:

  • Qualification concepts
  • Risk analyses, GAP analyses
  • IQ / OQ / PQ
  • Media systems (water systems, HVAC, clean rooms)
  • Qualification and validation of process plants (cycle development, temperature distribution studies)
  • Process validation
  • Cleaning validation
  • Computer system validation

GMP Compliance Consulting

The global regulatory environment is changing rapidly. It is a challenge for many companies to meet the increasing GMP requirements.

With our knowledge of the current international GMP regulations and the relevant industry standards, we help our customers to successfully pass inspections and audits and also provide support for technology transfers.

To guarantee GMP compliance in all functions and phases, we offer our customers consulting services throughout the entire product life cycle.

When introducing or optimising a Quality Management System (QMS), we place great emphasis on the balance between regulatory requirements and practical operational needs. We know how to tailor our consulting services to small and medium-sized companies – without compromising quality.

Within the scope of process validations, we provide support in the creation of concepts and the necessary documentation, including SOPs.

Our specialists in the area of GMP compliance are competent contacts for the fulfilment of the GxP requirements of FDA, EU, ICH and PIC:

  • Audit and inspection preparations
  • Training on GxP topics
  • Support for risk management
  • GAP analyses
  • Creation of qualification and validation concepts
  • Introduction or optimisation of Quality Management Systems
  • Process validation