A unified guide sets the requirements for establishing and operating pharmaceutical plants
LIBYA The Health Ministry in the Libyan government has adopted a Good Manufacturing Practice (GMP) guide for medicines, aiming to put in place a single comprehensive framework of requirements and standards for pharmaceutical plants, keep pace with international requirements and support the localisation of the pharmaceutical industry in the country.
Requirements for Establishing and Operating Plants
The ministry said the guide sets out the technical and regulatory requirements for establishing and operating pharmaceutical plants, from the management system, organisational structure and job descriptions through to facility design, ventilation systems and water treatment.
It also covers the layout of staff, raw-material and product movement inside the plant so that operations flow in line with good manufacturing practice.
Quality Laboratories and Suppliers
The guide includes requirements for quality-control laboratories, including chemical, physical and microbiological labs, as well as mechanisms for assessing raw-material suppliers.
It also sets requirements for installing equipment and verifying its performance, and for periodic maintenance programmes and qualification and accreditation plans.
International Standards for Local and Global Plants
The guide was prepared on the basis of international recommendations and standards, led by World Health Organization guidance, drawing also on legislation and requirements previously applied by the Health Ministry and the Pharmacy Administration.
The ministry said the guide lets local and foreign investors see the approved requirements for establishing and operating pharmaceutical plants in Libya.
It stressed that the requirements in the guide are the same standards used to assess global pharmaceutical plants that supply the Libyan market, ensuring the same level of requirements when pharmaceutical plants are built inside the country.
Localising the Pharmaceutical Industry
The ministry said adopting the guide forms part of efforts to localise pharmaceutical industries in Libya, develop the pharmaceutical manufacturing system, regulate investment in the field and strengthen the quality and safety of pharmaceutical products.
It added that this supports building a national pharmaceutical industry able to meet local market needs on global foundations and standards.
Within General Command Vision 2030
These measures fall under the targets of General Command Vision 2030 and within the Libyan government’s directives to develop the health sector, raise the efficiency of oversight and quality systems and improve health services for citizens.
