A complaint handling system is a procedure for receiving, reviewing and evaluating complaints in a […]
According to the Code of Federal Regulations (CFR) section 21 CFR 820.50, each manufacturer shall […]
Written procedures are the corner stone of any GMP manufacturing facility. Procedures are written to […]
The Code of Federal Regulations (21 CFR 211.194 Laboratory Records), states that laboratory records must […]
ICH guideline Q1A(R2), states that “the purpose of stability testing is to provide evidence on […]
Line clearance is an integral part of every facility’s standard operating procedure in order to […]
According to the Code of Federal Regulations (21 CFR 211.42 Design and Construction Features), any […]
A company recently received the following observation regarding CAPA: …. Procedures for corrective and preventive […]
January is a time when all facilities should revisit their quality strategy, and adjust it […]
Happy New Year! Let 2023 be full of adventure and growth. To help you prepare […]
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