The reasons for this observation in Warning Letter are discussed below;
The firm lacks a quality unit (QU) and approved written procedures defining QU responsibilities and controls.
In addition, the firm failed to establish adequate written responsibilities and procedures for:
• Batch release
• Manufacturing processes
• Laboratory deviations and CAPAs
• Complaints
• Recalls
• Handling of drug product returns and rejects
Whether you can imagine a Pharmaceutical company without a Quality Unit?
As one cannot imagine life without oxygen similar way if the roles & responsibilities of the Quality Unit will not be implemented, then do you think the discipline required for Compliance & Quality shall be maintained effortlessly?
If the procedures will not be approved then who will take responsibility that the procedures are accepted, reviewed & are in compliance with the guidance?
If the responsibilities will not be in writing then what can be the impact on the system?
If the procedures will be missing then how in the absence of a person who knows the accurate procedure another person will know?
How the absence of approved procedures people will take responsibility? Who shall be responsible for which procedure?
There is no need to tell what will be the compliance level.
Similar things might happen & company has suffered due to this.