Are You Scientifically Justifying Your Clean and Dirty Hold Times for Ancillary Equipment?

When it comes to cleaning validation for pharmaceutical manufacturing equipment, having proper scientific justification for […]

Are you properly utilizing production personnel to support process validation? 

In a recent FDA inspection, a company was cited for failing to utilize actual production […]

Is your firm sharing usernames and passwords for laboratory equipment?

Verification of lab data is a crucial aspect of ensuring compliance with established specifications and […]

Don’t Let Poor Training Records Derail Your FDA Compliance

21 CFR 211.25 specifies employee training and education must have “sufficient frequency to assure that […]

Are you properly initiating your CAPA Procedure BEFORE taking Corrective Action? 

A robust corrective and preventive action (CAPA) system is critical for maintaining compliance and product […]

Are You Properly Storing Batch Records?

A recent FDA inspection at a pharmaceutical manufacturing facility revealed serious deficiencies in the firm’s […]

Do you inspect your retain samples?

It is important to ensure that a reserve sample representative of each lot or batch […]

Do you have a Program for Evaluating your Suppliers?

According to the Code of Federal Regulations (CFR) section 21 CFR 820.50 Purchasing Controls each […]

Are you confirming the ID of your raw materials before use?

Manufacturing quality products requires using raw materials that meet your quality standards. According to the […]

Is the construction of your buildings suitable for easy cleaning and maintenance?

According to the Code of Federal Regulations (21 CFR 211.42 Design and construction features), any […]