SOP (Standard Operating Procedure) is the most important document for any pharmaceutical industry. Each person working is pharmaceutical industry has to follow instructions given in training to operate system and to maintain consistency of instruction given SOP is mandatory to control all operations. Medicine is the high-risk product consumed by sick or old people to maintain their health and quality of each dosage consumed should be accurate and precise till life cycle of product.
Why You Should Attend:
SOP is the final Instruction given to follow for uniform and consistent work flow in industry. SOP helps to maintain the quality of products till life cycle and to maintain the Quality of product from lot to lot and batch to batch. SOP writer should write clear and simple understanding language to have clear instruction for perfect working.
Seminar Agenda:
Overview of Documentation
– What is Document
– Importance Documentations
– Regulatory Requirements
Basics of Documentation requirement
– Quality Policy and Objectives
– Responsibility and Authority
– Internal Quality Controls
– Management Review
Resource Management
– Technical people
– Core Team for SOP preparation
– Responsibility
Management Responsibility
– Quality Policy and Objectives
– Responsibility and Authority
– Internal Quality Audits
– Management Review
Level of Documents
– Triangle of Documents
SOP on SOP
– Structure of SOP
– Content of SOP
– Gathering information to write SOP
– SOP management System
Collecting Raw Data for SOP
– Preparing Raw write-up for SOP
Assembling Data in Sequence
– Preparing flow of SOP
Preparation and Review
– SOP writing and review, Practical Approach
Who Should Attend:
- Quality Assurance Departments
- Quality Control Departments
- Manufacturing Departments
- Engineering Departments
- IPQA Departments
- Microbiology Professionals
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