Service Overview

Details

EU GMP Turnkey Solutions Process

GMP concepts describe general procedures for quality assurance tools essential for operation of a GMP system and thereby confirm, that product and processes are compliant to the guidelines and regulatory requirements.

This comprises a multitude of documents like work instructions, standard operating procedures, concepts for training, qualification, validation, deviation and change control management, handling of OOS results, self-inspections and much more.

As these documents assure efficient and error free operation of the GMP unit, they should fit to each other and to the size of the customer side.

An essential prerequisite for the efficient and practical application of the quality assurance tools is the deep knowledge about options and variation. This and the exact description of the requirements and processes allows the adequate adaption of the tools to the real need of your GMP system.

Hoaviet Cleanroom offers support for implementation of GMP concepts as a pure consulting service whereat our experts evaluate the situation and based on this give advices to the customer only.

On the other hand Hoaviet Cleanroom provides extensive preparation of instructions for each quality assurance tool required for this GMP unit.

Hoaviet Cleanroom employs a team of own consultants who are experienced and have a lot of hands-on expertise in EU GMP compliance issues. This team has already solved a lot of problems in different areas in pharmaceutical industry, the explanation for the fact, that Hoaviet solutions are often most suitable for customers realization. The consultants implement guidelines and official requirements in a goal and solution orientated manner always having in mind the practical and economical aspects for your company.

Regular training in GMP basics, at least once a year, is an official requirement for each employee of a GMP facility.

Hoaviet Cleanroom offers such trainings on two-day basis. The trainings are customized and focused on the products of the customer.

The participants learn what the GMP guidelines demands for their current products and processes thereby allowing a better understanding to each participant. This effect is intensified trough customized training instructions everyone gets before the training.

After an anonymized test everyone will get a GMP training certificate for the successful participation.

Valicare’s consultants have a deep expertise and a broad spectrum to follow up nearly each specific request regarding custom specific training topics.

Already established are trainings for the following subjects:

  • GMP basics
  • EN ISO 13485 & EN ISO 9001 Compliance
  • Riskmanagement and –analysis
  • Qualification & Validation
  • Validation of methods
  • Validation of processes
  • Microbiology
  • Operation and technology of cleanrooms