1.0 OBJECTIVE 1.1 To describe a procedure to maintain discipline inside the factory. 2.0 SCOPE 2.1 This Standard Operating Procedure is applicable to all employees/ visitor of the factory. 3.0 RESPONSIBILITY 3.1 Departmental officer/executive: shall execute this SOP. 3.2 All departmental head to ensure the compliance of this SOP. 4.0 ACCOUNTABILITY 4.1 Head –HR shall … Read more
1.0 OBJECTIVE 1.1 To describe a procedure for cleaning and sanitization of the factory to remove the dust, dirt and reduce the level of microorganisms for a clean and safe environment leading to a good quality product. 2.0 SCOPE 2.1 This procedure applies to all areas excluding core areas of the factory. 3.0 RESPONSIBILITY 3.1 … Read more
1.0 OBJECTIVE 1.1 To describe a procedure for personnel Hygiene to be maintained inside the factory premises. 2.0 SCOPE 2.1 This procedure is applicable to all the employees working in the factory 3.0 RESPONSIBILITY 3.1 Execution : All. 3.2 Internal Coordination : Officer of HR & Security Section. Overall responsibility : All Department Heads. 4.0 … Read more
1.0 OBJECTIVE 1.1 To describe the procedure for training and development of all the employees. 2.0 SCOPE 2.1 This procedure is applicable to all the employees of the plant. 3.0 RESPONSIBILITY 3.1 Human Resources (HR) Department is responsible for: 3.1.1 Identifying and communicating with the faculties in consultation with head of the departments. 3.1.2 Providing … Read more
sop for entry and exit of employee in factory premises 1.0 OBJECTIVE 1.1 To describe a procedure for maintaining discipline of entry and exit of employees in the factory premises 2.0 SCOPE 2.1 Applicable to all the employees of factory 3.0 RESPONSIBILITY 3.1 All employees: responsible to follow this procedure. 3.2 HR Department … Read more
1.0 OBJECTIVE To lay down a procedure for Sanitation of Raw & Purified water. 2.0 SCOPE This SOP shall be applicable for Sanitation of Raw & Purified water tank 3.0 RESPONSIBILITY Execution- Executive QC. Checking – Assistant Manager QC. 4.0 PROCEDURE 4.1 Drain water completely from the storage tank and scrub the tank wall by … 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