What does BRR stand for?

It is to this end that JAPM supported by SABEQ Program organized the Good Documentation Practices and Batch Record Review workshop to the Pharmaceutical Industry.

Merck's SOP states that all death and life-threatening adverse experiences require lot checks with batch record review.

AlBMR's cGMP consulting services include: specifications for raw materials and finished products; Standard Operating Procedures (SOP) for raw material and finished good testing; master manufacturing record and batch record review and analysis; SOPs and documentation for product complaints and returns; GMP self-evaluation and process improvement; site visits--assessment and gap analysis; quality assurance master plans; documentation and record keeping.

Areas reviewed included: annual product reviews, complaints, manufacturing investigations, material review board records, laboratory investigations, change controls, rejected lots, stability test reports, batch record reviews, in-process and finished product testing, select SOPs, laboratory equipment calibration/maintenance, employee training, and general laboratory controls and procedures.

Concerning the four ANDAs, Dodds and Phommachanh looked into the firm's batch record reviews, bioburden mixing studies, media fills records, stability samples, aseptic filter studies, manufacturing equipment, product variances and development reports.

Furthermore, consignees' inquiries were not always evaluated as possible complaints and, while batch record review was required for complaints, it was not always documented.