Absence of written procedures or failure to follow written procedures
FDA CFR directs that pharma organizations must create written standard operating procedures (SOPs) for production and process control. These SOPs must include all requirements for drug identity, strength, quality, and purity.
Probably the most significant concern for anyone responsible for implementing, deploying, and maintaining a quality management system is effectively documenting procedures and work instructions that are easy to understand and execute.
Failures in laboratory controls
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans or test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling or drug products conform to appropriate standards of identity, strength, quality, and purity.
Scientifically sound lab procedures are an enormous responsibility. Procedures, raw data, and management records are all necessary evidence of quality-driven operations.
Faulty production record reviews
There is a failure to thoroughly review any unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications, whether or not the batch has been already distributed.
There were 104 observations in 2022 of pharma companies that didn’t meet standards for the investigation of discrepancies or failures. CFR dictates that the pharma QC unit must review and approve all drug production and control records, including packaging and labeling records, to determine compliance with SOPs.
Improper cleaning /sanitizing/maintenance
Equipment and utensils are not cleaned, maintained, or sanitized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product.
FDA CFR dictates that equipment and utensils are sanitized, maintained, and cleaned appropriately to prevent malfunctions or contamination. In other words, if your company is making medicine, then the FDA wants to ensure that you’re working in a clean, sanitized environment.
Computer control of master formula records
Appropriate controls shall be exercised over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Pharmaceutical companies need to have some documents that are only available to leadership and other key stakeholders to edit or approve edits to maintain the integrity of those files.
