US FDA issues draft norms on drug-unit inspections

Proposed rules to be finalised a month later, after industry feedback

To smoothen the inspection process of drug manufacturing facilities across the globe, the US Food and Drug Administration (FDA) has come up with draft guidelines for scrutiny facilitation of such units. The idea is to ensure drug makers comply with norms and ease the inspection processes without delay or limiting the scope of it.

The proposed guidelines, reviewed by Business Standard, clearly specify conditions to be met by companies during inspections by the US regulator. In case of a failure on this account, it may be considered violation of law.

For instance, the draft says during inspection, if an FDA investigator requests for some records, which it has authority to inspect but the company fails to produce the required documents, it may be considered a violation. Similarly, under the draft rules, a facility cannot limit the scope of inspection by the US regulator by any means such as ordering discontinuation of manufacturing during the FDA inspection without a reasonable explanation.

Industry officials say though such guidelines would make inspections a stringent process, it is necessary to maintain the quality of medicines. They also view the guidelines more as a means to bring transparency than create obstacles for those selling drugs in the world's largest pharmaceutical market.

The regulator has asked the industry to offer comments on the draft guidelines within a month, after which the norms will be finalised. It has said the guidelines are recommendations and do not establish "legally enforceable responsibilities".

DRAFT GUIDELINES
Some of the rules proposed by the US Food and Drug Administration (FDA)

What might be considered delay:

• A facility does not agree to a proposed inspection start date and does not give a reasonable explanation for its failure to do so
• After scheduling an inspection, a facility requests a later start date without giving a reasonable explanation

Denial of Inspection:

• A facility rejects FDA's attempt to schedule an inspection
• A facility does not allow the FDA investigator to begin an inspection of a facility, even if it has been pre-scheduled

Limiting scope of inspection:

• A facility orders the discontinuation of all manufacturing for the duration of the FDA inspection without a reasonable explanation
• A facility limits direct observation of portions of the manufacturing process