The Ajay Bapat column: Pharma certification

We all have heard of some or the other requirements or regulations for pharmaceutical industries, which are being discussed at large platforms. Maybe the stakes involved are high.

The professionals in the pharmaceutical industry have been imposing the same on their business partners, mostly their vendors – some of them from the organised sector, but mostly unorganised entrepreneurs. If asked why, the answer is: “If we need to follow certain rules, we want our business associates to be a part of the game.”

Topics such as drug master files for material, safety standards, good manufacturing practises, such as treating effluent water – which is otherwise discharged in the ecosystem, and carbon emissions are being discussed at length at all forums.

There are few regulations, which are not in the extreme sensitive category for the industry, but are important for its allied business partners. It can be ISO certifications, basic knowledge of safety standards, GMP, or environmental protection. Let’s discuss a few of these.

AGMARK: Short for Agricultural Marketing, AGMARK is a quality grading and certification programme by the Directorate of Marketing and Inspection under Ministry of Agriculture in India, for export or domestic trades; not only for agricultural produce, but also for fruits, vegetables, livestock, spices and more. Few people confuse these with FSSAI, which is an agency for food standard and safety and comes under the Ministry of Health, Government of India.

OHSAS: It speaks about safety and standards in the area of occupational health for organisations concerned on controlling risks and improving performance. The clauses that are discussed the most are OHSAS18001 – which deals exclusively with risks, whereas OHSAS 45001 – which is a more dynamic, process-based approach, which considers both risks and opportunities. Few of the advantages for implementing these are, but not limited to, reduction of work incidents, prevention of ill health and work injuries.

ISO 14000: This is a set of rules and standards created to help companies reduce industrial waste and environmental damage. Companies can get ISO 14000 certified, as a framework for better environmental impact management, but it's an optional certification. This itself is an issue. As this is not a mandatory ruling, environmental damage is being seen worldwide.

The ISO 14001: This concentrates on managing a company's external environment just for regulatory compliance and for efforts in reducing pollution. In contrast, the OHSAS 18001 strives to ensure safety internally in the workplace by getting both workers and management involved in risk reduction. The ISO 14000 standards provide a guideline for organisations to systematically improve their environmental management efforts.

ISO 9000: This certification is pertaining to quality management and meeting customer’s quality requirements, achieving control of processes, and encouraging continuous improvement and the latest buzzword.

ISO 9001: It’s the world's most recognised Quality Management System (QMS) standard. Whereas ISO 9001 with the current version of 2015 specifies the requirements and criteria for the certification. It aims to help organisations meet the requirements of their customers and other stakeholders more effectively. This is achieved by building a framework to ensure consistent quality in the provision of goods and/or services.

PS9000: In the absence of mandatory GMP standards for the manufacture and supply of pharmaceutical packaging materials, the PQG developed the PS9000 standard for pharmaceutical packaging materials (incorporating ISO 9001). This well-used standard is recognised and acknowledged by the UK MHRA.

PQG certification: Certification to the PQG Certified Supplier scheme is given by independent, accredited and certification bodies to suppliers to the pharmaceutical and related industries that meet expected standards.  Suppliers that are certified with the PQG scheme are entitled to use PQG Certified Supplier logos on their company literature, which indicates that they conform to the GMP standards required for suppliers to the pharmaceutical industry.

Now, if these many certificates are to be given with so many organisations issuing certification, we need to have a body, which will assess the competence of organisations that provide certification, testing, inspection and calibration services. One such body is available in the UK under the name The United Kingdom Accreditation Service (UKAS) – a sole national accreditation body recognised by the British government – which has become a national body after Brexit.