EU GMP/GDP/GACP Audits and Licensing

Pharmaconsulta paves the way for your EU GMP or EU GDP audit to prepare for or to initiate 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 World Health Organisation (WHO) and European Medicines Authority (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.

The first step in any EU Pharma venture is Pharma License Acquisition. In order to engage in any pharmaceutical activity, one must have the proper licensing in place beforehand. At Pharmaconsulta, we are unmatched in this field, and have successfully acquired licenses on behalf of a host of international clients, ensuring a smooth and seamless transition for these clients when venturing into new business in Malta or the countries of the European Union.

Good Manufacturing Practice (GMP)

Good Manufacturing Practice (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 quality controlled to the quality standards appropriate for their intended use and as required by the product specification. GMP defines quality measures for both production and quality control. It also defines general measures to ensure that processes used in 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 EU GMP certified by:

  • creating and maintaining a quality system
  • provision of QP services
  • training of staff
  • preparation of site following our pre-inspection audit

This last step will trigger an inspection by an EU National Competent Authority for licensing the firm’s facilities as an EU GMP licensed manufacturing site.

Good Distribution Practice (GDP) (GDP)

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

We can provide you with a Responsible Person (RP) 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 (SOPs), quarantine, temperature mapping and pest control. We also provide staff training and inspection readiness to ensure a seamless supply chain and the achievement of the highest level of client satisfaction.

Good Agricultural and Collection Practice (GACP)

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).

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 of these materials.

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 an appropriate quality assurance system. – Ref: Doc. Ref. EMEA/HMPC/246816/2005.

Pharmaconsulta’s team of consultants has a number of years’ experience in the fields of agricultural and medicinal manufacturing. Our knowledge and experience are the basis for offering you the best strategies in aiding you to comply fully with the highest standards on the market. We offer site certification for GACP compliance to WHO, EU and Europam guidelines.

Medical Cannabis

The Medicinal Cannabis industry in Malta is growing very quickly.

Medicinal Cannabis itself has been legalized and can be prescribed in Malta. The therapeutic effects of the plant are known to help with conditions such as multiple sclerosis, epilepsy, chronic pain and ADHT.

The Maltese Government is also driving this industry forward by enticing manufacturers to locate or relocate to Malta for the growth and processing of medicinal cannabis through extensive industry regulation and incentive schemes provided through Malta Enterprise for the encouragement and support of the industry’s development here. Such manufacturers would also have access to Malta’s tax incentives, a booming economy and a highly educated, English speaking labor force.

It is worth noting that as manufacturers, companies growing medicinal cannabis in Malta require GMP certification.

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

I) Upgrade and certify the cultivation site to GACP standards which are compliant to EU GACP, WHO & Europam guidelines for GACP whereby the cultivation site can grow, harvest, cure, sort and pack plant parts to be sold to an EU GMP processing site.

II) Audit and upgrade a cultivation site to trigger an EU GMP inspection, which if successful would allow it to obtain an EU GMP license to be able to extract and process cannabis plant biomass and extractions as active substances to pass onto EU GMP licensed facilities for medicinal cannabis finished products.

Quality Management Systems

A quality management system (QMS) is a collection of procedures designed to achieve quality policy and objectives to meet customer requirements. It is defined as the organizational structure, policies, standard operating procedures (SOPs), processes and resources needed to implement a particular standard of quality management into a firm’s products or services.

In the pharmaceutical world, the QMS is of vital importance to protect the final user (the patient) from receiving a medicinal product which is defective or below its intended quality level.

At Pharmaconsulta, we can design your QMS and create SOPs to best suit your daily working processes, in the manufacture of medicinal products and food supplements (EU GMP), wholesale and distribution of medicinal products and active pharmaceutical ingredients (APIs), transportation of medicinal products, as per EU GDP guidelines, as well as cultivators of cannabis and herbal products as per EU, WHO and Europam GACP guidelines.

Pharmaconsulta Ltd can certify your quality system and scope of business, to be in compliance with current day standards expected by the increasing demand in accountability and quality control of today’s industry.

Creation of Standard Operating Procedures (SOPs)

In the face of a challenging regulatory environment, some leading pharmaceutical companies have found ways to improve quality and reduce costs significantly. To drive this kind of beneficial change, companies must first create a culture where quality objectives are transparent, well understood, and where these goals can be achieved by following an agreed set of procedures called Standard Operating Procedures (SOPs). Procedures are essential for any plant’s effectiveness and efficiency, and they are a regulatory requirement in the Pharmaceutical Industry. A typical pharmaceutical manufacturer has an average of 1200 – 1300 SOPs. A Parenteral Drug Association (PDA) survey found that a typical pharmaceutical company must manage an average of 1250 cGMP-required SOPs and that the average maintenance burden is 15,000 manhours per firm per year.

A Standard Operating Procedure (SOP) is a set of written instructions that documents a routine or repetitive activity which is followed by employees in an organization. The development of and adherence to SOPs is an integral part of a successful quality system. It provides the information required to perform a job properly and consistently in order to achieve predetermined specification and quality end-results.