In an effort to update the manufacturing standards of pharmaceutical products for the current global market requirements, the World Health Organisation (WHO) is planning to revise its Good Manufacturing Practices (GMP) guidelines for active pharmaceutical ingredients (APIs) soon.
This part of GMP is under scrutiny of experts and the WHO expert committee meeting to be held in the middle of October 2007 would discuss the need and details of revision. The new guidelines would be in line with the Q7A standard prepared by the International Conference on Harmonisation (ICH), according to informed sources from WHO.
The endeavour of the organization is to revise its one and a half decade old version of GMP norms for API manufacturing. The existing GMP for API has been implemented by WHO on 1992. However, most regulated countries like US and European Union have several times upgraded the manufacturing norms for active ingredients since its implementation. It is in this scenario, the WHO is looking for a change in its present norms, to include more comprehensive and up-dated standards for pharma ingredients.
The WHO officials clarifies that the current discussion is 'whether to revise or not' the WHO GMP guideline for APIs. "No decision has yet been taken. We will be starting to circulate an inquiry soon. The outcome will be discussed in the WHO Expert Committee dealing with quality assurance related issues. Their recommendation will be the basis for WHO's future actions," added the official sources from WHO.
However, some sources from WHO confirms that the relevant part of its GMP text is under revision and the norms would be same or equal to the ICH Q7A guidelines, in order to better the standards of products manufactured in plants certified by it.
The ICH Q7A has been developed by a working group of ICH formed in 1997 and the draft guidelines were published on 1999, though it was only on November 2000 that the final consensus document was adopted by the ICH steering committee. The guideline, earlier implemented by the three ICH regions - US, Japan and European Union - has been adopted by Canada and similar countries as the reference guide for the manufacture of APIs in a later stage.
The Q7A is designed as an appropriate system for managing quality of products and includes guidelines for all API manufacturers, contract manufacturers, agents, re-packers, re-labelers, brokers and traders. As part of its assertion on basic factory requirements for manufacturing APIs, the guideline insists on quality in building and facilities, process equipments, materials, production, laboratory controls, re-use of materials, human resource, quality management, validation and documentation.
The guideline specifies the importance of contract manufacturers and contract research laboratories, as Chapter 16 of the document describes the requirements for contract manufacturing and is titled as 'contract manufacturers, including laboratories'. The section purposely includes the words 'and laboratories' to make it clear that the chapter also applies to any laboratory, which may conduct analysis for the API manufacturer according to a specific request or agreement. The section also clearly says that all contract manufacturers (including laboratories) should comply with the GMP defined in the guidance.
While the section 4 clarifies the quality requirements of buildings and facilities, section 5 tells that the process equipment should be designed and constructed in such a way as to facilitate cleaning, sanitizing, maintenance (including repairing) and appropriate manufacturing operations (including adequate size) to be used within its qualified operating range.
Also, section 8 of this guideline explains that in-process sampling and controls, blending of intermediates or APIs, validation of blending and contamination control should be as per the quality standards.
However, the present WHO guideline covers a wide spectrum of manufacturing process, including production, quality assurance, validation process and other basic norms that are required for certifying drug development processes in new drug development programmes. The proposed revision of WHO guideline is expected to further strengthen the regulations, according to industry sources. The GMP certification from WHO is significant for Indian API manufacturers, at least for the medium and small scale API manufacturers who have been following the 1992 guidelines aggressively to export its bulk drug products.
"This landmark revision would change the manufacturing methods of a large number of small and med cap manufacturers in India, which supplies drugs to several countries, including 132 participant nations of WHO," industry sources added.
"Almost 30 to 40 per cent of the companies in India have WHO GMP for manufacturing bulk drugs. But, most of these companies have already upgraded their facilities to ICH Q7A, as it is the basic requirement for exports to the regulated markets. Apart, rest of the companies should anyway upgrade their facilities to the revised standards for their export operations," said Narayana Reddy, president, Bulk Drug Manufacturers Association, Hyderabad.
"The overseas customers are not interested in manufacturers unless the bulk drug producer sticks to the latest certification of the highest quality norms," he added. The WHO certified bulk drug manufacturers have to make considerable investments to maintain their business upon the revision of the guidelines.
The revised norms may ensure quality management system in place along with services of qualified personnel. It would in turn bring in more quality for the bulk drugs. However, the additional investment is likely to pose a challenge for a certain section of bulk drug manufacturers in the country.