Good Manufacturing Practice

 

Introduction

All medicinal products for human use manufactured or imported into Malta and the EU, including medicinal products intended for export, are to be manufactured in accordance with the principles and guidelines of Good Manufacturing Practice (GMP).

GMP is that part of quality assurance which ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation (MA). GMP is concerned with both production and quality control.

Good Manufacturing Practice Inspections

GMP inspections are conducted to assess compliance with EU GMP Guidelines as specified in the provisions of the Medicines Act, 2003 and relevant EU Directives. These inspections also ensure that the conditions of the manufacturing licence are being met. By ensuring  that EU GMP standards are met during the production of medicinal products one is ensuring that medicines that reach the patient are safe, of good quality and efficacious. The inspection process is a vital safeguard to public health.

There are various types of GMP inspections:

  • New applications - These types of inspections are conducted following an application for a manufacturing licence. A manufacturing licence can be recommended or rejected depending on the outcome of the inspection.
  • Renewals of manufacturing licences - Manufacturing licence sites are periodically inspected to assess compliance with GMP.
  • Follow up inspections - These inspections are conducted to follow up a previous inspection.
  • For cause inspections - These types of inspections may be warranted in specific circumstances or following a complaint.
  • Variation inspections - Variation inspections are conducted when an application to vary the manufacturing licence is received from the licence holder.

GMP inspections include inspections for:

  • Manufacture of medicinal products.
  • Manufacture of any dosage form of a medicinal product has to be in conformance with EU GMP Guidelines for the whole manufacturing process of the medicinal product until release on the market.
  • Manufacture of investigational medicinal products (IMPs).

IMPs are a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorisation when used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form. Manufacture of IMPs has to be in accordance with EU GMP.

  • Repackaging of medicinal products.

Any change to the packaging of medicinal products has to be conducted in accordance with EU GMP Guidelines and can only be done under a Manufacturing Licence specifying the type of repackaging activity being carried out.

  • Importation of medicinal products from countries outside the EU.

Importation of a medicinal product from a country outside the European Union requires a Manufacturing Licence. 

  • Manufacture of active pharmaceutical ingredients (APIs)

EU Directives specify an obligation for manufacturing authorisation holders to use as starting materials, only active substances which have been manufactured in accordance with the GMP guidelines for active substances. API manufacturers are issued with a GMP certificate only, unless the applicant specifically requests a manufacturing licence.

  • Quality control and microbiological laboratories to be used by manufacturers of medicinal products

Quality control and microbiological laboratories, including stability testing of investigational and marketed medicinal products, is regarded as part of the medicinal manufacturing process. Laboratories providing this service have to be operating in compliance with GMP. Stand alone contract GMP laboratories do not hold their own manufacturer's licence but are named on the manufacturer's licence who is using their services.

Good Manufacturing Practice Guidelines

EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines

Maltese legislation regulating the manufacture of medicinal products

S.L. 458.42 - Good Manufacturing Practice in Respect of Medicinal and Investigational Medicinal Products for Human Use Regulations. 

S.L. 458.36 - Manufacture and Importation of Medicinal Products for Human Use (Amendment) Regulations.

S.L. 458.47 - Good Clinical Practice and Requirements for Manufacturing or Import Authorisation of Investigational Medicinal Products (Human Use) Regulations.  

Applications related to Good Manufaturing Practice

Application for a Manufacturer's/Importer's Licence for Medicinal Products and/or Investigational Medicinal Products for Human Use 

Application for a Variation to a Manufacturer's, Importer's or Wholesale dealer's Licence

Application for a Certificate for GMP Compliance of a Manufacturer 

Application for Registration for API Import & Distribution Activity 

Circulars

New requirements for importation of Active Pharmaceutical Ingredients (APIs)

Further information

Organisation Management Service (OMS) integration with EudraGMDP -Human and Veterinary industry preparedness for more information click here

For further information please send an email on inspectorate.adm@gov.mt