Syed Asif Shah

Group Head Quality Assurance, Nabiqasim Group of Industries

Title: Quality Risk Management System in Pharmaceuticals

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Biography

Syed Asif Shah has done Masters in Chemistry and MBA in Marketing. He is a Trainer and Seasoned Quality professional having 18 years of diversified experience in pharmaceutical industry including Quality Assurance, QMS, Compliance, Audits, Data Integrity, Sterility Assurance, Aseptic and terminal Sterile techniques, Validation, Quality Control and Training,  Currently working in Nabiqasim industries as Group Head of QA, Managing Nabiqasim Group of Industries.

Nabiqasim industries, Manufacturer of Oral solid dosage, Oral liquid, Suspension, sachets, derma, Cephalosporin, Hormones, Sterile eye drops, Lyophilize, laxative enema products whereas Surge laboratories is a manufacture of Microencapsulated APIs, Liquid & Sterile Dry Powder Parenteral. Nabiqasim group is one the best export oriented organization of Pakistan.

Abstract

In the pharmaceutical industry every product and every process associated with risks. To maintain product quality throughout the product life cycle, too much time and resources are allocated. Risk is described in - recent guidance as a combination of the probability of occurrence of harm and the severity of that harm. The Quality Risk Management (QRM) approach initiated by regulatory agencies with recognized management tools along with support of statistic al tools in combination allows for a risk-based approach to quality management, thus ensuring that resources are deployed in a timely and expeditious manner to areas that need them most.

QRM improves risk awareness and accelerates detection of potential issues by analyzing and comparing existing data from a quality perspective to manage product quality, manufacturing processes, validation and compliance within a risk based Quality Management System. In addition quality risk management improves decision making if a quality problem arises. It should include systemic processes designated to co-ordinate, facilitate and improve science-based decision-making with respect to risk.

Quality Risk Management can be applied not only in the manufacturing environment, but also in connection with pharmaceutical development and preparation of the quality part of marketing authorization dossiers. The guideline applies also to the regulatory authorities in the fields of pharmaceutical assessment of the quality part of the marketing authorization dossier, GMP inspections and the handling of suspected quality defects.

ICH Q9 - Quality Risk Management provides an excellent high-level framework for the use of risk management in pharmaceutical product development and manufacturing quality decision making applications. It is a landmark document in acknowledging risk management as a standard and acceptable quality system practice to facilitate good decision-making wit h regard to risk identification, resource prioritization and risk mitigation / elimination, as appropriate.