THIS is apropos of the letter ‘Regulatory body’ (Feb 3). I propose that a competent drug regulatory national authority should be established to look after products and activities of licensed pharmaceutical companies. Such companies should produce only approved licensed drugs, and their activities should be regularly inspected by some competent national authority.

Personnel responsible for approving a batch for release should always ensure that marketing authorisation and manufacturing authorisation requirements (licence) for the product have been met for the batch concerned. The principles and guidelines as laid down by the company in the light of guidelines published by WHO must be followed.

Moreover, all necessary scientific checks, tests and trials should be performed and account taken of the production conditions and manufacturing records, and any planned changes or deviations in manufacturing or quality control should be notified in accordance with a well-defined reporting system before any product is released.

Such changes may need notification to, and approval by, the drug regulatory authority, all necessary production and quality control documentation should be completed and endorsed by supervisors trained in appropriate disciplines, appropriate audits, self-inspections and spot checks are carried out by an experienced and trained staff.

Self-inspection and quality audits are also imperative for companies. The purpose of self-inspection is to evaluate the manufacturer’s compliance in all aspects of production and quality control.

The self-inspection programme should be designed to detect any shortcomings in the implementation of the company and to recommend the necessary corrective actions.

Self-inspections should be performed routinely, and may be, in addition, performed on special occasions, e.g. in the case of product recalls or repeated rejections or when an inspection by the health authorities is announced.

All recommendations for corrective action should be implemented. The procedure for self-inspection should be documented regularly and there should be an effective follow-up programme. The frequency of self-inspection should preferably be at least twice a year.

Quality audit should be performed rigorously by the drug regulatory authority to supplement self-inspections with a quality audit.

A quality audit consists of an examination and assessment of all or part of a quality system with the specific purpose of improving it. Such audits may also be extended to ingredient suppliers and contractors as well.

By implementing the above suggestions, pharmaceutical organisations will come at par with world-renowned drug-producing companies.

HABIB HYDER LAGHARI Canada