Un-Planned Deviation – II in Pharma Details for Deviation No. ________ Department : Production Investigation start date : Investigation completion date: INVESTIGATION TEAM S.No. Name Designation Department 1. Production Head Production 2. Production Manager Production 2. EngineerTechnologist Production 4. QAOfficer Quality Assurance 5. QA Head Quality Assurance Sr.No. Product Batch No. BMR … Read more
Un-Planned Deviation in Pharma Investigation Report Description of Deviation: The document entry of dispensing and cleaning records is not recorded by the respective operators. Type of deviation: Un-Planned Deviation Class of Deviation: Minor Date of investigation: Department: Warehouse Date of deviation Observed: Investigations start date: Investigation completion date: INVESTIGATION TEAM S.No. Name Designation Department 1. … Read more
SOP LIST (Quality Assurance) S. No. SOP Title 1. Preparation, Approval, and Control of Standard Operating Procedures 2. Vendor Approval 3. Change Control 4. Preparation, Approval, Review and Control of Technical Directions for Manufacture of Drug Products. 5. Preparation, Approval and Control of Specifications and Standard Test Procedures for Raw Materials, Packaging Materials, … Read more
SOP on Sampling of Raw Material Objective: To lay down the procedure for the sampling of raw material. Scope: This procedure is applicable for the sampling of raw material. Responsibility: Chemist or above Accountability: Head – Quality Control Procedure: Sampling of Raw Materials: Raw material sampling shall be initiated after receiving the “GRN” from the … Read more
List of SOPs Quality Control Sr. No. SOP Title 1. SOP on entry & exit procedure in Quality Control Department 2. SOP on sampling of raw material. 3. SOP on intermediate and finished product analysis and approval 4. SOP on analysis of sample by contract laboratory 5. SOP on sampling procedure of packaging material. 6. … Read more
SOP FOR STABILITY STUDY IN PHARMA INDUSTRY OBJECTIVE: To lay down the procedure for collection, storage and analysis of stability of samples. SCOPE: This SOP shall be applicable for stability study of samples in Quality Control Department in Pharma Industry. RESPONSIBILITY: Officers/Executive-Quality Control shall be responsible for follow that procedure. ACCOUNTABILITY: Manager- Quality Control and … Read more
Total Organic Carbon in Water in Pharma Industry This method for determining total organic carbon (TOC) indirectly measures the total· amount of organic substances present in water for pharmaceutical use in Pharma Industry. The molecules of organic matter in water are oxidised to produce carbon dioxide which is then measured in an instrument and from … Read more
Checklist for Laboratory in Pharma Industry Laboratories should be audited regularly and at least once per year. Auditing is an independent activity and separate from self-inspection. Auditing activities could include reviewing SOPs, worksheets, laboratory notebooks, balance calibration records, working control data, pipette calibration records, equipment monitoring logs and other related items for producing test results. … Read more
Effectiveness of Antimicrobial Preservatives in Pharma industry The efficacy of antimicrobial preservation of a pharmaceutical preparation on its own or, if necessary, with the addition of a suitable preservative has to be ascertained during the development of the product. The primary purpose of adding antimicrobial preservatives in Pharma industry to dosage forms is to prevent … Read more
Organization and Personnel in Pharma industry as per USFDA Responsibilities of quality control unit (§ 211.22) in Pharma industry (a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority … Read more