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
handling of reference standard and preparation of working standard 1.0 OBJECTIVE 1.1 To describe a procedure for handling of reference standard and Preparation of Working standard. 2.0 SCOPE 2.1 This procedure applies for handling of reference standard and Preparation of Working standard to the Quality Control Department 3.0 RESPONSIBILITY 3.1 Officer /Executive … Read more
sop for water sampling and analysis 1.0 OBJECTIVE 1.1 To describe a procedure for water sampling and analysis. 2.0 SCOPE 2.1 This procedure is applicable to the Quality control department 3.0 RESPONSIBILITY 3.1 Officer/Executive – QC 4.0 ACCOUNTABILITY 4.1 Head – QC 5.0 PROCEDURE 5.1 Following type of water are to be collected … Read more
1.0 OBJECTIVE 1.1 To describe procedure for procedure for Validation of ex.cel worksheets. 2.0 SCOPE 2.1 This procedure is applicable for Validation of excel worksheets of Quality Control Department 3.0 RESPONSIBILITY 3.1 Officer /Executive – QC 4.0 ACCOUNTABILITY 4.1 Head – QC 5.0 PROCEDURE 5.1 Operating Procedure 5.1.1 The Validated excel worksheets shall be stored … Read more
sop for laboratory cleaning 1.0 OBJECTIVE 1.1 To describe a procedure for Laboratory cleaning. 2.0 SCOPE 2.1 This procedure is applicable to the Quality control department 3.0 RESPONSIBILITY 3.1 Officer/Executive – QC 4.0 ACCOUNTABILITY 4.1 Head – QC 5.0 PROCEDURE 5.1 Clean all the reagent bottles & shelves with clean lint free cloth. … Read more
sop for stability of volumetric solutions 1.0 OBJECTIVE 1.1 To describe a procedure for Stability study of standardized Volumetric solution and confirm the validity period of the Volumetric Solution. 2.0 SCOPE 2.1 This procedure is applicable for Evaluation of Stability of standardized Volumetric solution and confirm the validity period of the Volumetric Solution … Read more