Gap Analysis

Passing audits and inspections is becoming more and more challenging. A GMP-compliant system is not permitted to exhibit any major gaps. You are uncertain whether the implementation meets the GMP requirements? Then a gap analysis by experts is urgently needed. GMP compliance must be put to the test! A detailed report on findings and specific recommendations for improvement are the goals.

Gap Analysis by Independent GMP Experts

Defects and deviations – the findings - are reliably evaluated based on the many years of experience. Trusted in all sectors, familiar with a wide variety of products and processes – gempex is able to provide support in almost all topics:

  • raw materials, excipients, active ingredients
  • finished pharmaceutical products (e.g. solid dosage forms, sterile products)
  • pharmaceutical, chemical and/or biotechnology production processes
  • production, quality control, warehousing, logistics and IT
  • integrated quality assurance systems
  • calibration, qualification and validation concepts
  • and much more

Recording the Situation On-Site – Detailed Improvement Proposals

The data from a detailed questionnaire sent in advance provides the GMP consultants with initial, important basic information. Investigating the situation on- site though a system analysis follows. The observations are discussed and possible solutions for the implementation of corrective actions are jointly defined. Detailed consultancy is provided on top.

Priorities and Practical Proposed Actions in the Form of a To-do-list

The final report provides a quick overview of the overall gap analysis results. Observations and findings are classified and prioritised in a to-do list. Detailed and specific proposed solutions and actions provide a solid basis for developing an improvement program and defining deadlines and costs. This ensures an overview is maintained at all times and reduces stress.

Fast, Precise and with a Cost Guarantee

A gap analysis can be arranged on short notice. Depending on the scope and availability of documents and information, initial results are available after just six to eight weeks. A fixed price offer protects you against unwelcome surprises and ensures planning reliability. Standardised processes, defined timelines and clear agreements guarantee quality. A team of several GMP experts can be provided in highly urgent cases.

Benefits

  • transparency regarding the status quo
  • secure basis for decision making with priorities to establish the next steps
  • neutral perspective of external experts
  • benchmark according to the state of the art and meeting official requirements
  • gempex is a partner and supports the subsequent implementation all the way to the audit or inspection if needed