Quality Assurance

SOP On SOP – Initiation of new SOP In the Pharma Industry The initiator of SOP shall prepare the SOP draft. The SOP initiator shall record the relevant details in the “New SOP Initiation Form (SIF)”, attach the SOP draft along with this form and forward it to the concerned …

REGULATORY IMPACT ON OOS Stability study required OOS should be reported to RA OOS batch should not be sold to the Regulatory market OOS batch can not be blended with a fresh approved batch OOS batch can not be directly sold to the market Reporting Test Result Result: Averaging Appropriate …

OOS RECORDING PROCEDURE REPORTING TO THE LABORATORY SUPERVISOR RECORDING AND NUMBERING OF OOS INVESTIGATION BY ANALYST LABORATORY TESTING APPROVAL BY LAB. SUPERVISOR TESTING BY ANALYST PROCEDURE OF OOS INVESTIGATION: A written record of the review should include the following information A clear statement of the reason for the investigation. A …

REGULATORY RECOGNITION OF SECONDARY WORKING STANDARDS (1) Human Drug CGMP Notes, Vol 9, Number 3, 2001 (Internal FDA Publication): Q: Can a company use reference standards from sources other than the USP? A: Yes. Using a source other than USP can be acceptable provided the reference standard incorporates the critical …

Process validation protocol A written plan stating how validation will be conducted, including test parameters, product characteristics, production and packaging equipment, and decision points on what constitutes acceptable test results. The process validation protocol is defined as the experimental plan that design thoroughly the validation programmed. Protocol of the Process …

Change Control – Strategies for Successful Company-Wide Implementation Good Manufacturing Practices (GMP), manufacturers must comply with numerous requirements. Industry must document instructions for manufacture and quality control procedures. They must specify materials needed and define the basic conditions required for a reproducible quality, such as suitable rooms, qualified facilities, trained …

Hold Time Study Protocol 1. Objective \ Scope 1.1. Hold time study data shall give the assurance of the maximum allowable hold times for bulk and in-process drug products. Generally, one lot can be used for validating hold times if any inconsistency results were observed then another two lots can …

CRITICAL AND MAJOR DEFICIENCIES Compliance and enforcement measures are dependent upon a number of factors, including the significance of violations such as a “Critical” deficiency and a large number of “Major” deficiencies, the history of the site, potential risks to products, and assessment of the manufacturer’s proposed corrective actions. Where …

GMP Deficiencies in Pharmaceutical Industry “Critical and Major deficiencies” The GMP Deficiencies findings of a Good Manufacturing Practice (GMP) inspection can have a substantial impact on both your organization and, subsequently, public health. If the GMP Deficiencies found are classified as significant, they may necessitate cessation of manufacturing activities and/or product withdrawal from the …

INSPECTIONS/AUDITS 1. Manufacturing Process i. Drug Product (Dosage Form) In many cases, clinical production or trial runs of a new drug are produced in facilities other than the ones used for full-scale production. The facilities and controls used for the manufacture of the batch or batches are audited. For a …