Quality assurance process

Our consultants perform frequent GMP audits and gap analyses. These may be design and engineering audits relating to a particular facility or they may be audits of validation activities, or cGMP audits of an existing operation or mock inspections to all regulatory standards. Our audits can include laboratories, manufacturing procedures, quality assurance release, compliance and recall procedures, purchasing and vendor approval procedures and computer systems.

Success in validation depends upon careful planning at all levels. Our services frequently include the preparation of validation plans ranging from plans for a single processing line to site-wide Validation Master Plans (VMP).

The objectives of the plans are to define the scope of, and responsibilities for, the validation activities within the project (or the site), to identify the GMP regulatory requirements, to identify and plan the resource requirements, to define the common standards and specifications which apply across the entire project (or site) and to define the applicable procedures and general acceptance criteria for all protocols (not necessarily the system specific criteria).

The Validation Master Plan also serves as a management tool for introduction of the project to regulatory authorities, senior management, auditors and other third parties as neede. It is the 'map' for the validation project.

Our consultants have the capability to provide a wide range of in-house training courses using a combination of formal presentations, workshops and discussion topics, or they can consist of equipment demonstrations or one-to-one practical training in validation topics.

All our training is accompanied by relevant course material and certificates. If required, our consultans can carry out formal assessments of the training provided.

The training courses offered include general GMP and technology related topics.

We often find that clients have a specific problem or question that requires a regulatory interpretation such as a practical interpretation of a particular guideline. Our consultants can bring their own wide experience to resolve such issues. It is often the case that other clients have had similar problems and a resolution has been found which can be applied to another facility.

Sometime clients wish to get comments directly from the regulatory authorities without being identified. In these instances our consultants can act on behalf of the client and maintain the client confidentiality.

Our consultants have conducted many mock inspections to prepare companies for pre-approval or routine GMP inspections. The scope of these has ranged from inspections of specific operations through to full site GMP audits. Inspections can be undertaken against any international GMP standards and findings are reported in a constructive manner and options for remedial action are presented.

Our Group contains a number of consultants and specialists with manufacturing, QA and development experience working in major pharmaceutical manufacturing companies. Using this experience we have been able to assist clients in developing validation plans and rationales for cleaning validation projects.

Our consultants have particular expertise in the field of aseptic processing, antibiotic processing, antibiotic powders, fermentation and biotechnology processes, tablets and capsules and highly automated processes. Our portfolio of projects ranges from products in the phases of clinical development, through new product start-ups, to modification and re-engineering of existing processes.

In order to conduct process validation it is necessary to ensure that all components of the facility validation are complete, i.e. utilities, equipment, environment and automation. The combination of these with the appropriate material and use of trained personnel will result in product which is fit for purpose.

Click here to view the Process Validation Services Diagram