Top 15 Reasons for Reciving Form 483 Obsevation in Pharmaceutical Companies

Top 15 Reasons for receiving Form 483 observation in Pharmaceutical Companies

A FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator has observed any conditions that in their judgement may constitute violations of Food Drug and Cosmetic Act and Related Acts.

Folowing are top reasons for issuance of 483 FORM-

 

Scientifically Sound Laboratory Controls:

Laboratory controls do not includes the establisment of scientifically sound and appropriate specification, standards, sampling plans and test procedure designed to assure that components, drug product containers, closures and in-process materials.

Calibration/Inspection/Checking Not Done:

Routine calibration, inspection, checking of automatic mechanical or electronic equipment is not performed according to a written program designed to assure proper performance.

Cleaning /Sanitizing/Maintenance:

Equipment and utensils are not Cleaned, Maintained, and Sanitized at appropriate intervals to prevent Malfuctions, Contamination that would alter the Safety,Strength and Quality or Purity of the drug product.

Control Procedures to Monitor and Validate Performance:

Control procedures are not established which monitor the output, validate the performance of those manufacturing processes that may be responsiblefor causing variability in the characteristics of in-process
material and the drug product.

Testing and Release for Distribution:

Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specification, identity and strength of each active ingredient prior to release.

Environmental Monitoring System:

Aseptic processing areas are deicient regarding the system for Monitoring Environmental Conditions.

Absence of Written Procedures:

There are no written procedures for production and process controls designed to assure that the drug products have the identity, strenght, quality, and purity they purport or are represented to possess.

Procedure not in Writting, Fully Followed:

The responsibilities and procedure applicable to Quality units are not in writting or Followed.

Procedure for Sterile Drug Products:

Procedure designed to prevent microbial contamination of drug products puporting to be sterile are not established, written or followed.

Investigation of discrepancies failures:

There is a failure to thoroughly review any unexplained discrepancy the failure of a batch or any of its components to meet any of its specification whether or not the batchhas been already distributed.

Lack of or Inadequete Process Validation:

A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to establishing procedures.

Quality Audits -Lacks of or Inadequate Procedure:

Procedures for quality audits have not been adequately documented.

CAPA Documentation:

Corrective and Preventive action activities and or results have not been documented.

Lack of Complaint Procedures:

Procedure for receiving, reviewing, and evaluting complaint by a formally designated units have not been established

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