1.0 OBJECTIVE: To lay down a procedure for Hot Work Permit. 2.0 SCOPE: This SOP is applicable for the requirement of Hot Work Permit whenever Welding, Cutting, Burning, Drilling, Soldering or any other open flame work is carried out at …………….. 3.0 RESPONSIBILITY: Officer / Executive – ...

1. Pre-Requisites to Begin Cleaning Validation 1.1. Cleaning Validation Strategy and Protocols are approved. 1.2. Equipment used for most of the products should be identified 1.3. SOP for Equipment Cleaning has been established (draft) 1.4. Sampling and Analytical Methods are validated 1.5. A list of ...

Quality, safety, and efficacy can be summed up as the three validation principles in product design and construction. Inspection of the finished product and work-in progress are insufficient for quality assurance. The production process is reviewed at each stage to ensure that the final product meets ...

Validation is defined as per various bodies EC, ICH, FDA, WHO as given below: According to European Commission 1991: Validation-“Act of proving, in accordance of GMPs that Any…” process actually leads to expected results. 2000: “Documented evidence that the process, operated within established ...

1. Definition of OOS and OOT Out of specification (OOS) is defined as a result that falls outside the predetermined specifications or established acceptance criteria set by the manufacturer and/or the laboratory. In simple terms, the result of a stability test conducted by a Quality Analyst (QA) should ...

The following parameters are to be considered during the performance qualification of HVAC: 1. Calibration test certificates of instruments 2. Training records of validation team 3. Pressure drop across the HEPA & fine filters 4. Air velocity measurement & calculation of Air changes 5. Integrity ...

1.0 Introduction 2.0 Number of Intermediates and APIs batches produced 3.0 Review of output for all Isolated Intermediates and Finished Products 4.0 Review of Critical Quality attributes of In-process, Isolated Intermediates and Finished Products 5.0 Summary of changes made during the year with respect ...

I. Introduction II. Organization and Personnel A. Responsibilities of the Quality Control Unit B. Personnel Qualifications C. Personnel Responsibilities D. Consultants III. Buildings and Facilities A. Design and Construction Features B. Lighting C. Ventilation, Air Filtration, Air Heating and Cooling D. ...

Chapter 1: Quality Management – Principles – Quality Assurance – Good Manufacturing Practice – Quality Control – Audits – Quality Evaluation Audits – Critical Procedures Chapter 2: Organisation and Personnel – Principles – Responsibilities of Key ...

Primary Package Primary packaging is the smallest unit of distribution/or use and is defined as the packaging which is in direct contact with the formulation. For example, bottles for syrup, jar for cream, and pouch for powder, syringes, ampoule, flexible bag, etc. The basic aim of primary packaging ...