GMP/GDP/GACP Audits & Licensing

Pharmaconsulta paves the way for your EU Good Manufacturing Practice (EU GMP) or EU Good Distribution Practice (EU GDP) audit to trigger an inspection by a National Competent Authority (NCA) in the EU. Audits for certification as compliant entities for Good Agricultural and Collection Practice (GACP) standards as per WHO and EMA, and Europam guidelines are also carried out by our team.

Auditing is a crucial part of GMP and GDP that ensures adherence to GMP and GDP requirements and is essential for continued licensing and operations. Pharmaconsulta is also able to provide employee training for GMP/GDP/GACP Audit reviews as well as on site GMP/GDP/GACP Audits and detailed GAP analysis.

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 a site for inspection by an EU national competent authority for licensing as an EU GMP licensed manufacturing site, and training of staff.

Good 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 the 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 Responsible Person to handle all or part of your GDP requirements. We specialise in the creation and implementation of quality systems including the 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.

In order to ensure appropriate and consistent quality of medicinal plant/herbal substances, it is necessary to establish a good agricultural and collection practice for herbal starting materials (GACP). The concept of Good Manufacturing Practice for the manufacture, processing, packaging, and storage of Active Pharmaceutical Ingredients (APIs) also applies to medicinal plants/herbal substances. In the case of herbal preparations, the production and primary processing of the medicinal plant/herbal substance has a direct influence on the quality of the API. Due to the inherent complexity of naturally grown medicinal plants/herbal substances and the limited analytical techniques to characterise constituents solely by chemical or biological means, reproducible quality of starting materials of herbal origin requires an adequate quality assurance system for the collection and/or cultivation, harvest and primary processing. The GACP Guideline on good agricultural and collection practice does not fall directly under GMP guidelines in the traditional sense. However, these considerations should be used as a basis for the establishment of such an appropriate quality assurance system.
– Ref: Doc. Ref. EMEA/HMPC/246816/2005.

Pharmaconsulta’s team of consultants have a number of years’ experience in the agricultural and medicinal manufacturing fields. Our knowledge and experience are the basis for offering you the best strategies in aiding you to comply fully with the highest standards available on the market.

The Medical Cannabis industry in Malta is growing extremely fast.

Medicinal Cannabis itself has been officially legalized to be prescribed in Malta. The therapeutic effects of the plant are known to help with conditions such as multiple sclerosis, epilepsy, chronic pain, and ADHD. The Maltese Government is also making leaps forward by enticing manufacturers to locate in Malta for the growth of medical cannabis through the Malta Enterprise. Such manufacturers would also have access to Malta’s tax incentives, a booming economy and a highly educated demographic. It is worth noting that as manufacturers, companies growing Medical Cannabis in Malta require GMP certification. Good Manufacturing Processes (GMP) is a system for ensuring that products are consistently produced according to quality standards.

Auditing is a crucial part of GMP that ensures adherence to GMP requirements and is essential for continued licensing and operations. We provide employee training for GMP Audit reviews.

For cultivation sites outside Malta and outside the EU, wanting to send material to an EU GMP licensed facility for further processing, Pharmaconsulta can offer the following strategic solutions to move cannabis plant products:

  • Upgrade and certify the cultivation site to GACP standards which are compliant to EU GACP, WHO & Europam guidelines for GACP where the cultivation site can grow, harvest, cure, sort and pack plant parts to be sold an EU GMP processing site.
  • Audit and upgrade a cultivation site to trigger an EU GMP inspection to obtain an EU GMP license to be able to extract and process cannabis plant biomass and extractions as the active substances to pass onto EU GMP licensed facilities for medicinal cannabis finished products.

Request more information about our services