The World Health Organization (WHO) has issued draft guidelines on Good Pharmacopoeial Practices (GPhP) and is looking for the industry to comment before March 10, 2015.
The pharma industry has now appreciated this effort as it further enables them to adhere to total stringent quality standards.
Pharmacopoeias are embedded in their respective national or regional regulatory environment. Retrospective harmonization has proven difficult to achieve. Prospective harmonization may be easier but presents certain challenges after the initial work has been done, as the maintenance process over time of the pharmacopoeial standards needs to be viewed within a long-term perspective, said WHO in its draft recommendations.
Developments in science and medical practice, globalisation and the presence of spurious/falsified/falsely labelled/counterfeit (SFFC) products require pharmacopoeias to constantly revise. Convergence and reinforced collaboration among pharmacopoeial committees and regulators, supported by adequate interaction with industry, will assist in facing new challenges and resource constraints, it stated.
A first initiative to reopen the discussion on international harmonization of quality control specifications on a global scale was taken in a side meeting of the 10th International Conference of Drug Regulatory Authorities (ICDRA) entitled: ‘Pharmacopoeial Specifications – Need for a Worldwide Approach?’ in Hong Kong in June 2002. This further led to discussions among regulators during the 11th ICDRA meeting held in Madrid in 2004.
It was agreed to develop the GPP under the auspices of the WHO Expert Committee on specifications for pharmaceutical preparations, benefiting from its well-established international standard-setting processes and procedures. These processes include an global consultation process, involving all stakeholders and users in the development process. The final guidance would then be presented, in line with the procedure, to WHO’s 194 Member States and pharmacopoeial authorities.
The primary objective of the WHO Good Pharmacopoeial Practices (GPhP) guidance is to converge approaches and policies in establishing pharmacopoeial standards, which willsupport regulatory authorities in controlling the quality of pharmaceutical ingredients, their finished products and other materials and will provide a tool by which the user or procurer can make an independent judgement regarding quality, thus safeguarding the health of the public.
Now the GPhP has a set of principles that provides guidance for national pharmacopoeial authorities (NPAs) and regional pharmacopoeial authorities (RPAs) which facilitates the appropriate design, development, maintenance, publishing and distribution of pharmacopoeial standards. It is designed to facilitate collaboration among pharmacopoeias leading to recognition of published standards between NPAs and RPAs, increasing access to affordable, quality medicines.
The establishment of GPhP would strengthening of global pharmacopoeial cooperation; providing stakeholders with a better understanding of how pharmacopoeial standards are developed and maintained in a transparent manner. It would improve cooperation between NPAs/RPAs besides the industry and the regulators. It would facilitate the global convergence of pharmacopoeial standards, to reduce duplication of work.
While the implementation of the GPhP by NPAs and RPAs is voluntary it is recommended and encouraged, as a high level of participation will result in greater benefit to the stakeholders and ultimately to patients, stated the WHO in its draft guidance.