HANDLING OF CHANGE CONTROL Change Control: Review, evaluation, approval and monitoring of changes to processes, procedures, specifications, analytical methods, vendors, machines, facilities and utilities. The change can be permanent or temporary. Permanent Change: Any planned introduction, addition, deletion or modification of Manufacturing Facility, Equipment, Utilities, Manufacturing Process, Material/Product, Specifications, and …
Read More »Assigning Manufacturing and Expiry date
Sop on Assigning Manufacturing and Expiry date To lay down a procedure for assigning manufacturing and expiry dates to the finished products being manufactured. & This SOP is applicable for assigning manufacturing and expiry dates to the finished products being manufactured at (Pharmaceutical Company Name). Assigning Manufacturing and Expiry date – …
Read More »SOP Template: Operating Standard Procedure
SOP Template: Operating Standard Procedure SILDENAFIL CITRATE TABLETS Purpose: Mention the intended use of the SOP in this column. It is a statement, which justifies the need of the SOP. Scope: Mention the application of the SOP in this section. It shall describe the extent of areas covered by the …
Read More »Standard Operating Procedure – How to Create an SOPs Effective
Standard Operating Procedure – How to Create an Effective SOPs Purpose: Purpose as first point; an overview of the intention of preparation of Standard Operating Procedure shall be briefly mentioned under this heading. SILDENAFIL CITRATE TABLETS Scope: Scope as second point; describes the site(s) / location(s) / plant(s) and/ or …
Read More »SOP ON SOP-STANDARD OPERATING PROCEDURE/GENERAL TEST PROCEDURES
SOP ON SOP-STANDARD OPERATING PROCEDURE/GENERAL TEST PROCEDURES PURPOSE: To describe a procedure for preparation, review, approval, revision and control of Standard Operating Procedures and General Test Procedures. SCOPE: Applicable to all Standard Operating Procedures and General Test Procedures. RESPONSIBILITY: Author/ Initiator of respective section shall be responsible for preparation or …
Read More »Annexure – I for Anual product quality Review
Annual Product Quality Review Report Product Description Product Name: Generic Name: Label Claim: Strength: Packaging Types Available: M.F. Nos. Batch sizes available: Markets Shelf Life Indications Time Period Covered for APR ___________________ to ______________________ Batches Manufactured: …
Read More »Product Quality Review (PQR) SOP
Product Quality Review (PQR)/Annual Product Quality Review APQR: Annual Product Quality Review – An organized and Comprehensive summary of a product, analytical and Customer data associated with a pharmaceutical product. Quality trends: Quality trends which include in-process and quality control data should be prepared and alert limits (trend limits) should be established …
Read More »Handling of Deviations SOP
Handling of Deviations SOP Any non-conformance /disobedience in written approved procedures (like standard operating procedure, standard test procedure, BMR, etc.) of the quality system in the organization is called deviation. SILVER SULPHADIAZINE AND CHLORHEXIDINE CREAM Objective of Deviations : To describe a procedure for handling deviations that may occur during the execution …
Read More »Cleaning Policy of Area & Equipment SOP
Cleaning Policy of Area & Equipment SOP Objective: To lay down the procedure for the Cleaning Policy of the Area & Equipment. Scope: This Standard Operating Procedure is applicable to all the departments at the formulation plant. Responsibility The production Operator/ Technician shall be responsible for cleaning. Production & QA …
Read More »SOP of Operating Procedure for Tablet Hardness Tester
SOP of Operating Procedure for Tablet Hardness Tester Objective:To lay down the Operating procedure for Tablet Hardness Tester. Scope:This Standard Operating Procedure is applicable for formulation plant of (Write Pharmaceutical Company Name with Location). Responsibility Trained worker / Operator shall be responsible for operating of the equipment as per this …
Read More »Good Documentation Practices SOP
Objective of Good Documentation Practices : To lay down the procedure for Good Documentation Practices in the facility. Scope: This standard operating procedure applies to all departments involved in documentation activities throughout the facility of the Pharmaceutical Company. Responsibility: All employees of Quality Assurance, Quality Control, Production, Warehouse, Engineering, Personnel …
Read More »Question & Answer on ICH For Pharma
Question & Answer on ICH For Pharma Question and Answer on ICH Q7 Question and Answer on Q8 ,Q9 and Q10 For More Pharma Updates Visit –https://pharmaguidances.com
Read More »Management ,Materials and Safety as per WHO in Pharma
WHO in Pharma Management and Infrastructure Quality health services depend on effective health management and strong infrastructure. The World Health Organization (WHO) is the world’s leading authority on public health, providing guidelines and recommendations to countries around the world to improve health governance and infrastructure. Management: Leadership and Governance: The …
Read More »WHO GUIDLINE FOR PHARMA PRODUCTION
WHO GUIDLINE FOR PHARMA PRODUCTION WHO good manufacturing practices WHO good manufacturing practices for pharmaceutical products: main principles(Annex 2, WHO Technical Report Series 986,2014) Active pharmaceutical ingredients (bulk drug substances) (Annex 2, WHO Technical Report Series 957,2010) Pharmaceutical excipients (Annex 5, WHO Technical Report Series 885,1999) WHO good manufacturing practices for sterile …
Read More »sop on Handling of FBD bag
sop on Handling of FBD bag Objective:To lay down a procedure for handling of FBD bag. Scope:This SOP is applicable receipt, issuance, usage cleaning and retrieval of F.B.D Bag to the formulation plant of (Pharmaceutical Company Name). Responsibility Operator/ Technician of production shall be responsible for issuance, usage, cleaning and …
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