Learn in Detail about the Procedure (SOP) of Good Documentation Practices | Good Documentation Practices FDA Guidance | 5 Principles of Good Documentation Practices. 1.0 AIM: To lay down procedure on Good Documentation Practice in Pharmaceuticals areas. 2.0 PURPOSE: The purpose of this Standard Operating Procedure is to define the entry in the document records … Read more
Learn About SOP of SOP (How to Write SOP by implementing Different Fonts, Size, Title, Logo, Stamps, Formats, BMR/ BPR, Spec/STP, protocols, Worksheets, Reports, and Logbooks, and Annexures as per the Pharmaceutical Guidelines). 1.0 OBJECTIVE: 1.1 To lay down the procedure for the preparation of SOP (SOP on SOP), Format, Numbering, Review, Approval, Implementation, Distribution, … Read more
Standard Operating procedure on SOP on Temperature Mapping in RM, PM, FG, and Control sample Area 1.0 Objective: To Lay down the Procedure for Temperature Mapping in PM, RM, FG, and Control Sample area (Storage Area).2.0 Scope: 2.1 This SOP shall apply to all storage areas in Pharmaceutical industries.3.0 Reference: In –House 4.0 Responsibility:4.1 RM, … Read more
Objective: To initiate, incorporate, approve and record changes to the master documents. Scope: This Sop is applicable for changes to the master documents. Responsibility: All the functional Heads. Accountability: Head – Quality Assurance. Filling procedure for Document Change Control DCC No: Document change control number is entered, and DCC No., will be allotted using the … Read more
Objective: To initiate, incorporate, approve and record changes to the master documents. Scope: This Sop is applicable to the Credence Pharmaceuticals for changes to the master documents. Responsibility: All the functional Heads. Accountability: Head – Quality Assurance. Documentation:Document Change Control -D083ARevision History -D084AFilling procedure for Document Change Control -(D083A)DCC No: Document change control number is … Read more
1.0 OBJECTIVE: 1.1 To define SOP on Change Control to be made in the authorized documents, validated methods, process, procedures, facilities, and equipment. 2.0 RESPONSIBILITY2.1 Assistant / Chemist / Executive – To initiate the Change Control Form.2.2 Respective Department Head – To evaluate and justify the required change.2.3 Other Departments Heads – To review and … Read more
Discover the effective process for conducting planned internal quality audits within the pharmaceutical industry. Learn how to optimize quality assurance practices while ensuring compliance with regulatory standards. Gain insights into enhancing pharmaceutical audit procedures and achieving operational excellence. 1.0 PURPOSE: 1.1 The purpose of this procedure is to implement a system for planned internal quality audits … Read more
Learn about the Standard Operating Procedure for the Collection of Swab and Rinse Water Samples, including their purpose, scope, responsibility, procedure for Swab Sampling, Sampling frame, Rinse Water Sampling, and Annexures. 1.0 Purpose: 1.1 To lay down the Standard Operating Procedure for the collection of the swab and rinse water samples2.0 Scope: 2.1 This SOP is applicable to all the … Read more
Learn About Standard Operating Procedure on IPA 70 % Preparation including their, Purpose, Scope, Procedure, frequency, and Annexures. 1.0 Purpose: To lay down the Standard Operating Procedure for the Preparation of 70 percent v/v Isopropyl Alcohol Solution. 2.0 Scope: This SOP applies to the preparation of 70 percent v/v Isopropyl Alcohol Solution. 3.0 Procedure: 3.1 Requisition for Isopropyl … Read more
Learn About Standard Operating Procedure on Storage and Hold time Study for Products along with their Purpose, Scope, Responsibility, Definition, Procedure, Selection of Test parameters, Sampling Interval/volume, and container, Hold time study at different stages, and Documentation. 1.0 Purpose: 1.1 To lay down Standard Operating Procedure for Storage and Hold Time of Starting Material, Intermediate, and Bulk Products. … Read more
Standard Operating Procedure for Coding and Calibration of Standard Weight, Scope, Responsibility, Precautions, Frequency, Procedure, and Yearly Calibration of Analytical Weight and Standard Weight. 1.0 Scope: The SOP is applicable for the Coding and Calibration of Standard Weight including analytical balance in the various departments at the plant. 2.0 Responsibility: 3.0 Precautions:3.1 Check the validity of the calibration … Read more
Standard Operating Procedure for Acceptable Quality Level (AQL) includes; Purpose, Scope, Responsibility, Precautions, Procedure, Classification of Defects for AQL, and AQL Charts. 1.0 Purpose: To lay down the standard procedure for an acceptable quality level for semi-finished tablets to evaluate physical attributes before packing. 2.0 Scope: This sop is applicable to all tablet products manufactured at the … Read more