The workshop «Risk analysis in planning of validation at pharmaceutical manufacture»

On 31 January – 01 February, 2019, within the joint program of promoting implementation of the best practices in the Russian pharmaceutical industry, FSI «SID & GP» and Pharmstrategy, Ltd. will hold an open expert-advisory workshop on the topic «Risk analysis in planning of validation at pharmaceutical manufacture».

It is commonly known that within the quality assurance system validation is one of the key tools to confirm that processes, utilities and the pharmaceutical product itself have been properly developed, implemented and are under control.

According to effective GMP requirements, validation shall be applied throughout the whole product life cycle, and the decisions in terms of the scope and volume of qualification and validation shall be based on risk assessment. The effective validation policy at the facility is able to significantly reduce the risks of non-conformities with the requirements of regulatory authorities.

At the same time, even individual validation-related non-conformities detected during GMP inspections are categorized as major or critical for the reason that they undermine the quality of commercially manufactured drug products.

The workshop will demonstrate the interrelations between regulatory requirements for validation and risk analysis at pharmaceutical manufacture. The methodological recommendations on the application of quality risk management methods and tools will be discussed.

A particular emphasis will be given to discussion of the most frequent non-conformities witnessed during regulatory GMP-inspections as applied to validation and risk analysis at pharmaceutical manufacture.

An assessment of changes in expectations of the inspectorate in relation to risk analysis and validation due to the application of GMP rules as established by the Eurasian Economic Commission in Resolution No. 77 dd 03 November, 2016 will be covered.

Lectures:

• Validation at pharmaceutical manufacture: regulatory requirements, general trends and recent regulatory changes
• Risk management at pharmaceutical manufacture: regulatory requirements, general trends and methodological recommendations
• Analysis of the inspections’ practice as applied to validation and risk management. The most frequent non-conformities
• Risk analysis as a tool of controlling the validation activities: a traditional and a modern approaches, the changeover strategy

Team work:

• Case study for detection of non-conformities with GMP requirements as applied to validation and risk management
• Case study and development of the plan of validation activities within CAPA