A blog about Pharmaceutical Quality Control, Quality Assurance, Microbiology, Production and Regulatory updates provided by Regulatory agencies. This video explains the basic concept and fundamentals behind an SOP and also gives an introduction to what goes into making an SOP. SOPs for pharmaceuticals related to Quality Assurance, Quality Control, Production, Maintenance, Utility and Human Resource are listed here. We do not guarantee the accuracy of this information or any results and the user is advised to take any decision or action on his/her sole discretion & responsibility. Quality assurance is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. 7.0 ANNEXURE: 7.1 Nil. Mail us at: info@pharmastate.com. SOP for SOP SOP for Training SOP of Allocation of Room numbers SOP of Organogram & Job Responsibility SOP of Protocol Numbering SOP of Role & Responsibility of the QA Department SOP of Documentation & Data Control SOP of Validation & Qualification Protocol SOP of Qualification Planner SOP of Calibration Policy SOP of Qualification Policy … QA SOP’s Read More » Pharma Industry Guidelines, Quality Assurance, Useful Formats, Validation. On 8th to 16th Jan’ 2021 January 7, … Follow Pharma Beginners. A list of Standard Operating Procedure for Pharmaceutical Quality Assurance Department required During Quality System Management Of Regulatory approved Manufacturing Sites. PharmaState DNA is having four pillars: Quality, Transparency, Innovation & Benchmarks. Pharma SOPs Standard Operating Procedures (SOPs) is a written procedure for any process or system that is followed during the operation of any system or equipment. December 26, 2020 / 0 Comments. 6.3 QMS - Quality Management System . Home Quality Control Quality Assurance Microbiology Production SOPs Validation GMP Audit Ask Question Documents Quality Assurance Following are the articles related to pharmaceutical quality assurance and quality management system for pharmaceutical industry those are helpful for new as well as experienced pharmaceutical professionals. December 26, 2020 / 0 Comments. 4.0 RESPONSIBILITY: QC Personnel shall be responsible for: Openings for Production/ Packing/ Soft Gel Dept -Apply On or before 7th Jan’ 2021 7.0 ABBREVIATIONS SOP : Standard Operating Procedure QA : Quality Assurance Mfg. XQA-001 (Preparation, Approval, Authorization, Control and Revision of SOPs). : Manufacturing Date Exp. 2.0 Scope This Standard Operating Procedure is … SOP for Qualification of Quality Control analyst SOP A blog about pharmaceutical quality control, quality assurance, microbiology, production and regulatory updates provided by regulatory agencies. : Expiry Date C&F : Carrying and Forwarding ZBM : Zonal Business Manager RBM : Regional Business Manager 8.0 ANNEXURE 2, Good manufacturing practices and inspection. It is an obligation that ensures manufacturers meet the needs of end-user needs in terms of safety, quality, efficacy, strength, reliability and durability. Recent Post. Walk-In Interviews for Multiple Departments – Quality Control / Quality Assurance / Production / Stores / Maintenance Departments @ Vital Pharma More Details Eris Lifesciences Pvt. 7.0 ANNEXURE: 7.1 Nil. Standard Operating Procedure (SOP) and Guideline for preparation, approval, and revision of Site Master File (SMF). Pharma Industry Guidelines, Quality Assurance, Quality Control, SOPs Important SOPs for Quality Assurance in Pharmaceutical Industry Date: 28/08/2018 Author: PharmaState Blog 0 Comments SOP's QA Pharma pathway-February 28, 2017 4 1.0 Objective To lay down a procedure for the approval of vendors for raw & packing material and De-qualification and … 1.Drug and narcotic control – standards 2.Drug industry – standards 3.Pharmaceutical preparations – standards 4.Biological products – standards View all posts by PharmaState Blog. Roller Compactor Machine – Operation & Cleaning. Standard Operating Procedures (SOPs) is a written procedure for any process or system that is followed during the operation of any system or equipment. – 2nd ed. Reproduction and Distribution of the same without written permission is prohibited. SOP For Batch Release of Finished Product Quality Control A blog about pharmaceutical quality control, quality assurance, microbiology, production and regulatory updates provided by regulatory agencies. 6.2 API - Active Pharmaceutical Ingredient. Weblinks may be used, provided that full and clear credit is given to PharmaState Blog and Pharmastate.com with appropriate and specific direction to the original content. SOP for Password Policy and Data Backup and Storage for Computer Systems. Pharma SOPs (29) Pharmaceutical companies (1) Production (15) Production SOPs (15) QA SOPs (4) QC SOPs (2) Quality assurance (5) Quality Control (13) sterile (1) Test (2) Trouble shooting (2) Uncategorized (2) Validation (7) Warehouse SOPs (1) Water (1) Jasleen Kaur a post graduate M. Pharm (Q.A.) https://www.pharmaguideline.com/p/sop-for-quality-assurance.html A global pharmaceutical company had experienced increased deviations and claims over the past year, which alerted them to deterioration in product quality. Roller Compactor Machine – Operation & Cleaning. END OF THE DOCUMENT Facebook Twitter. For the latest updates pertaining to this compilation visit the relevant website. Pharma Industry Guidelines, Quality Assurance, Quality Control, SOPs Important SOPs for Quality Assurance in Pharmaceutical Industry Date: 28/08/2018 Author: PharmaState Blog 0 Comments SOP on Change Control A blog about pharmaceutical quality control, quality assurance, microbiology, production and regulatory updates provided by regulatory agencies. 6.4 SOP - Standard Operating Procedure. personnel qc sop responsibilities of qc department sop qc Published by PharmaState Blog This is a platform for people working in the pharmaceuticals industry for Discussions, Jobs, News updates, Professional Profile display space and company business pages. The purpose of this SOP is to describe the procedure for analyst/reviewer qualification. SOP For Line Clearance. Biophore India – Walk-In Interviews for Quality Assurance / Production Departments on 9th Jan’ 2021 @ Visakhapatnam More Details Aurobindo Pharma Ltd – Walk-In Interviews for Multiple Positions in QA / QC / Production / Packing on 9th & 10th Jan’ 2021 SOP's QA Pharma pathway-May 14, 2017 0 1.0 Objective To lay down Procedure for Disposal of Expired or Obsolete Raw Materials. A blog about Pharmaceutical Quality Control, Quality Assurance, Microbiology, Production and Regulatory updates provided by Regulatory agencies. 6.1 QA - Quality Assurance. Biophore India – Walk-In Interviews for Quality Assurance / Production Departments on 9th Jan’ 2021 @ Visakhapatnam More Details Aurobindo Pharma Ltd – Walk-In Interviews for Multiple Positions in QA / QC / Production / Packing on 9th & 10th Jan’ 2021 With regard to pharmaceuticals, quality assurance can be divided into major areas: development, quality control, production, distribution, and inspections. Post category: cGMP / Checklist / Health & Safety (EHS) / Maintenance Sops / QA Sop / SOPs Post comments: 0 Comments Standard Operating Procedure (SOP) for cleaning of Pre-filters, Microvee filters, and cartridge filter of the equipment ( AHU, FDV, Autocoaters, FBD, RLAF, LAF, and Dust Collector ) … Reproduction and Distribution of the same without written permission is prohibited. END OF THE DOCUMENT 4.4 General Guidelines For Preparation of the SOP: It is preferable to use positive sentence structure … Find more at https://pharmastate.com, Click to share on Twitter (Opens in new window), Click to share on Facebook (Opens in new window), Quiz: Bio-pharmaceutical Innovation Trends from 1996 to 2015 (20 years), US FDA approves OXERVATE (Cenegermin) first ever drug with an indication for management of Neurotrophic Keratitis (a rare disease affecting the cornea) on 22th Aug 2018, Generate Pharma Business Leads with B2B feature, https://www.youtube.com/watch?v=onLhjDx7UR0, Approved Covid19 Vaccines till December 22, 2020, Top 10 (Ten) Global Pharmaceutical Companies 2020 | Top Ranking Pharma Companies In The World, ABCDE of Intelligence for Professional Growth, Preparation, review, approval and control of SOPs, Preparation, approval and control of master batch documents, Issuance and control of batch manufacturing documents, Preparation, review and control of site master file, Issuance and maintenance of equipment and instrument logs, SOP of handling regulatory and external audits, Numbering system of equipment/instruments, Document archival, retention and destruction, Expiry date assigning policy of finished product, Management of reference/retention samples, Entry and exit procedure in production and microbiology area, Rounding off and interpretation of results, Handling of typographical errors in documents. QA person review the batch record to ensure the data enter in the batch record is legible if QA person found any kind of data integrity issues then the appropriate action is taken as per the SOP. is a senior pharma writer. © PharmaState Blog and pharmastate.com | Pharmaceutical Industry Guidelines, SOPs, News, Views & Articles by Industry Experts. Pharmaceutical Guidelines. Pharma Industry Guidelines, Quality Assurance, SOPs. Pharma SOPs (29) Pharmaceutical companies (1) Production (15) Production SOPs (15) QA SOPs (4) QC SOPs (2) Quality assurance (5) Quality Control (13) sterile (1) Test (2) Trouble shooting (2) Uncategorized (2) Validation (7) Warehouse SOPs (1) Water (1) 6.4 SOP - Standard Operating Procedure. In case of QA SOPs, the Location QA Head shall authorize all the SOPs except the SOP No. Recent Post. SOPs in Editable MS-Word Format 6.5 OOS - Out of Specification. SCOPE :This SOP shall be applicable for in process controls during tablets manufacturing of pharmaceutical company. RESPONSIBILITY:Production /Quality Assurance Executive/Officer shall Be responsible for follow the procedure mentioned in this SOP. CVP : Cleaning Validation Protocol. 3.0 REFERENCES: In House. Responsibility Head QA, Head production Plant head Procedure Change control: Change control … Quality Assurance Department Functions in Pharmaceuticals : Quality Assurance Department shall function for assuring the quality of all the Products manufactured, at every stage of manufacturing / processing of Drug Products. SOP On In-process Control During Tablets Manufacturing OBJECTIVE: To lay down the procedure for In process Controls during Tablet Manufacturing. Pharma Industry Guidelines, Quality Assurance, Quality Control, SOPs, Copyright Notice: This Article/SOP/Compilation/Published Content is protected by Indian & International Copyright Laws. 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