EU GMP /GDP Compliance

Good Manufacturing Practice
GMP

Good Manufacturing Practices (GMP, also referred to as ‘cGMP’ or ‘current Good Manufacturing Practice’) is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification. GMP defines quality measures for both production and quality control and defines general measures to ensure that processes necessary for production and testing are clearly defined, validated, reviewed, and documented, and that the personnel, premises and materials are suitable for the production of pharmaceuticals and biologicals including vaccines.

GMP also has legal components, covering responsibilities for distribution, contract manufacturing and testing, and responses to product defects and complaints. Specific GMP requirements relevant to classes of products such as sterile pharmaceuticals or biological medicinal products are provided in a series of annexes to the general GMP requirements.

We can assist you in becoming GMP certified by creating and maintaining a quality system, provision of QP services, preparation of site for inspection and training of staff.

What is a GMP audit?

A GMP audit is an audit carried out on a manufacturing company to verify its compliance with the guidelines of good manufacturing practices. These are based on principles stated in Directives 2003/94/EC and 91/412/EEC. European pharmaceutical regulations for both manufacturing and distribution are applied to Malta.

How often is a GMP audit required?

The frequency of GMP audits should be established according to the risk assessment of the manufacturing operations.

What are the GMP audit requirements?

A GMP audit must cover all the aspects described in the GMP guidelines which are relevant to the manufacturing operations of the company in question.

How to prepare for a GMP audit?

Companies should ensure that an adequate day is chosen for the audit to enable smooth running of the audit process without interference with the routine manufacturing and regulatory operations. Files/documents required during the audit (including archived records) should be very well organized and readily available. The manufacturing areas that could be restricted during manufacturing operations should be accessible on the day of the audit. Likewise, ALL key personnel should be available.

Normally auditors provide the necessary guidance before the audit is carried out by requesting documents before the audit, providing a detailed audit-plan and discussing the scheduling of the audit with the company.

Additional planning for the day of the audit may include arrangements for travelling and accommodation for the auditors as well as adequate planning regarding provision of food. These should be discussed with auditors during the pre-audit correspondence arrangements.

From a technical perspective, companies might opt to have a Standard Operating Procedure describing the processes to follow when preparing for an audit. One major point to remember is to review any Corrective Actions, Preventive Actions (CAPA) established for previous audit findings and ensure they have been adequately implemented and maintained so as to prevent escalation of classification of findings.

How to prepare staff for a GMP audit?

Well-trained Staff in GMP/GDP should not require any special preparatory guidance – however, a review of their training records to ensure they are up to date with the latest amended and approved procedures is mandatory and any employees who have not yet covered their training as per SOP schedule should be encouraged to cover their training and when applicable, training assessment.

Additionally all members of staff with the exception of regulatory personnel should be instructed not to interfere with the progress of the audit and only provide basic information on their own manufacturing operations if asked to do so during the audit.

Checklist for GMP inspection

A GMP audit checklist is often created by the auditors to ensure they cover all the areas pertaining to the manufacturing operations of the company. This is not normally provided to the company before the audit, but may be created based on the audit plan.

Alternatively, a checklist could be created to cover all aspects of GMP related to the company’s specific operations and included as an annex to the above mentioned SOP describing the processes to be covered before an audit.

What happens if you fail a GMP audit?

Audits may result in one or more “critical” findings – this does not mean that the company has “failed”, but that immediate action needs to be taken to address the issues identified during the audit. If the issue cannot be immediately resolved due to the complexity of proposed CAPA’s, a clear time frame and action plan should still be provided together with a justification explaining why the issue requires the proposed period of time to be addressed. Once the finding is resolved, evidence of resolution should be provided to the auditor.

How can we help you pass a GMP audit?

Pharmaconsulta auditors have several years experience both in the manufacturing (GMP) and in the wholesale dealing (GDP) industry. This ensures that adequate guidance could be given to avoid common pitfalls specific to the Maltese pharmaceutical industry scenario.

Good Distribution Practice

Warehousing & LogisticsGood Distribution Practice (GDP) is concerned with all aspects of the proper distribution of medicinal products for human use. GDP is part of GMP, which focuses specifically on purchase, receiving, storage and export of drugs intended for human consumption. GDP regulates the division and movement of pharmaceutical products from the premises of the manufacturer of medicinal products, or another central point, to the end user thereof, or to an intermediate point by means of various transport methods, via various storage and/or health establishments.

We can provide you with a Resposible Person to handle all  or part of your GDP requirements. We specialise in creation and implementation of quality systems including creation of Standard Operating Procedures, quarantine, temperature mapping and pest control. We also provide staff training and inspection readiness to ensure a steady supply chain and the highest client satisfaction.