The Indian Pharmaceutical Alliance (IPA), a representative body of 20 research based pharmaceutical companies in India, has released guidelines on good documentation practice (GDP) and process validation (PV) as part of its ongoing efforts to help the domestic drug makers achieve parity with global benchmarks in quality.

Both the guidelines, released at the IPA's two-day conference held on February 23 & 24, 2018, were documented by IPA Quality Forum comprising Lupin, Cipla, Dr Reddy's Laboratories, Sun Pharma, Cadila Healthcare, Torrent Pharmaceuticals along with global consultancy firm, McKinsey. The guidelines were vetted by subject matter experts and regulatory agencies-- US FDA, UK MHRA and WHO.

GDP and PV are an essential part of Good Manufacturing Practices (GMP), adhering to GDP, PV helps prevent fallacies within various processes, such as product quality and safety, state of manufacturing facilities.

India received 14 drug GMP warning letters in the F/Y- 2017 which is an increase of 40 per cent annually. Also, FDA issued import alerts in six of the 14 warning letters, says a study conducted by BioAsia along with knowledge partner Deloitte.

However the number of warning letters from US FDA to Indian pharmaceutical companies have declined in 2017 as against 2015, lot still needs to be done to raise the bar of Indian manufacturers.

The domestic industry received 29 per cent of US FDA warning letters in 2017 as compared to 50 per cent warning letters in 2015 due to improvement in quality standards and regulatory compliance, says a study conducted by IPA and McKinsey.

The guidelines on PV and GDP released by IPA is seen as an attempt to help Indian drug makers raise the bar at par with global standards.

The PV guidance provides useful support for the implementation of a lifecycle approach to pharmaceutical PV.

In pharmaceutical manufacturing, process validation (PV) is collection and evaluation of data-- from the process design stage through commercial production-- that establishes scientific evidence that a process is capable of consistently delivering a quality product. It ensures that quality, safety and efficacy by design are built into the product.

It contains information that enables manufacturers to implement globally-compliant PV programmes. As per life cycle philosophy, process validation spans the product lifecyle, linking process development, validation of the commercial manufacturing process and its maintenance during routine commercial production.

The guidance is applicable for the PV activities conducted for new and existing drug substance, drug product. It can be applied as a risk assessment (gap analysis) in those cases-- for example, third party manufacturers and packagers who may have policies not aligned with this guidance-- in order to determine mitigation strategies.

Transparent interaction between teams collecting data, performing risk assessments and transferring information is essential to the PV effort.

The three-stage PV lifecycle classification (Stage1- Process Design, Stage 2- Process Qualification and Stage 3- Continued Process Verification) is used in this guideline.

GDP guideline aims to describe the requirements of maintaining complete, accurate, truthful; and verifiable data in all cGXP documents that are needed to be maintained as per regulatory requirements and various governmental regulations.

It highlights the application of data management procedures for all GMP documents. It lays down guidelines for preparation, recording and correction of data and maintenance of records throughout the lifecycle of a document. It helps to understand who, when, where, why and how to complete the relevant activities and provides evidence to show whether these have been completed as expected.

The principles of GDP are applicable to both paper and electronic data or records file manually or generated electronically in GxP environment.

To ensure that all relevant individuals are trained on the principles of GDPs and are following them, the department head needs to ensure refresher training of the persons involved in the GMP activities, says the GDP guideline.

Last year IPA released guidelines on data reliability as part of its continuing efforts to help improve the overall standards of the Indian drug industry.

The guidelines deal with key aspects such as building culture, awareness and capability, process design, data reliability risk detection and mitigation, technology and governance.