admin validation protocol for volumetric solution 0.1M ammonium Thiocyanate 1. Approval: This document is prepared by the validation and the GMP compliance team Under the authority of Quality Control Manager. Hence this document before being effective shall be approved by QA team. 2. Purpose: To establish documented evidence, on how the quality of a … Read more
microbiological assay of cyanocobalamin or vitamin B12 1.0 OBJECTIVE To describe the procedure for determine the assay of Cyanocobalamin or vitamin b-12 by biological method using E. Coli mutant MTCC -452. 2.0 PURPOSE It is the policy of (Analytical Division) that a written procedure shall be followed for determine the assay of Cyanocobalamin or … Read more
sop for monitoring of ultraviolet efficiency LAF and pass box 1.0 OBJECTIVE 1.1 To describes a procedure for monitoring of UV light efficiency and burning hour of LAF & Pass box. 2.0 SCOPE 2.1 This procedure applicable for monitoring of UV light efficiency and burning hour of LAF & Pass box. in Microbiology Laboratory … Read more
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
1.0 OBJECTIVE 1.1 The objective of this SOP is to define the procedure for line clearance from QA before commencement of new or further processing steps. 2.0 SCOPE 2.1 This SOP is applicable for line clearance from QA before commencement of new or further processing steps 3.0 RESPONSIBILITY 3.1 Officer / Executive – Quality Assurance … 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