1.0 OBJECTIVE The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and enables recommended storage conditions, retest periods, and shelf lives to be established. 2.0 … Read more
Media Fill validation Protocol for Liquid Injection (Ampoule) Index Sr. No. Contents Page No. 1. Approvals 2. Overview 3. Responsibility 4. Pre Requisite Checks 5. Filling and Stoppering Operations 6. Methodology Of Validation 7. Precautions 8. Revalidation 9. Frequency 10. Final Report 11. Report Approval 12. Appendix 1.0 Objective The objective of this … Read more
1.0 OBJECTIVE 1.1 To describe a procedure for hold time study of different dosage forms at various stages of processing.. 2.0 SCOPE 2.1 This SOP is applicable for hold time study of tablets, liquids manufactured 3.0 RESPONSIBILITY 3.1 Officer/Executive QA shall be responsible for preparation of a protocol and execution of studies as per approved … Read more
1. The stability of a formulation product should be determined prior to marketing and also prior to adoption of any significant changes in the formulation or manufacturing procedures or packaging materials that may affect the shelf-life of the product 2. Stability study should be carried out a product in each package type in which it … Read more
1.0 OBJECTIVE The objective of this policy document is to establish the ABC LABORATORIES PVT.Limited requirements and criteria for conducting stability studies, establishing shelf lives, determining appropriate storage and transportation conditions and assigning expiry dates for products under development as well as for routine production batches. 2.0 SCOPE The scope of this policy is: 1. … Read more
SPECIFICATION OF PURIFIED WATER AS PER USP/BP/IP Purified water very useful and largely in the pharmaceutical Aid (solvent) production pharma industrial as preparation of tablet capsule liquid Ointment and parental preparation Purified water also to be use for all test and Assay and volumetric solution. According to drug Act is produced by distillation deionization or … Read more
sop for Operation of Bore Well 1.0 Objective To lay down procedure for Operation of Bore Well. 2.0 Scope This Standard Operating Procedure is applicable for Operation of Bore Well, to be followed at formulation plants 3.0 Responsibility 3.1 Officer / Executive Engineering shall be responsible for the execution of this procedure. 3.2 Engineering Manager … Read more
sop for minutes of meeting 1.0 OBJECTIVE 1.1 The objective of this SOP is to define the procedure for record the minutes, objective, summary & conclusion of convened meetings. 2.0 SCOPE 2.1 This SOP is applicable for all designated persons from each department 3.0 RESPONSIBILITY 3.1 Asst. Officer or above –Quality Assurance – Prepare … Read more
preparation of master formula record 1.0 OBJECTIVE 1.1 The objective of this SOP is to define the procedure for numbering system for master formula record (MFR). 2.0 SCOPE 2.1 This SOP is applicable for numbering system for master formula record (MFR) 3.0 RESPONSIBILITY 3.1 Officer–Quality assurance-Prepare the SOP and follow-up the SOP accordingly 3.2 Asst. … Read more
sop for vendor selection and Evaluation 1.0 OBJECTIVE 1.1 The main objective of a pharmaceutical plant is to produce finished products for the patients’ use from a combination of materials. The quality, timely delivery and cost of incoming materials are the critical aspects that will affect the final product. So special attention is to be … Read more