SOP & QUALITY AUDIT

1. TOPIC :- STANDARD OPERATING PROCEDURE & QUALITY AUDIT CHHATRAPATI SHIVAJI COLLAGE OF PHARMACY DEORI ( GONDIA ) SUBJECT :- QUALITY ASSURANCE Represented by :- SANGAM RAUT Guided By :- C. Badwaik Sir

2. SOPStandard Operating Procedure is defined as a set of step by step written instructions intended to a document how to perform a routine activity. For a pharmaceutical industry, SOP act as its back bone. It is an integral part of Quality assurance (QA) which provides details of appropriate quality, cost and time constraints. • Objectives: • To maintain the quality control and quality assurance. • To serve as a training document for teaching users about the process for which the SOP was written. • To facilitate consistent conformance to quality system requirements and to support data quality. • To provide guidelines for accurate and timely data collection. • Uniformity of performance. • Efficiency and quality output. • Reduce miscommunication and failure to comply with industry regulations. • To carry out operations correctly and always in same manner.

3. Benefits:• Provides information to perform job properly.• To provide people with all safety, health, environmental and operational information necessary to perform the job properly.• Serves as a training document for users.• Minimizes variation and promotes quality. • Also provide, consistency.• Useful tool for training new members of staff.• SOP assists to ensure that GMP is followed and achieved at all times.• SOPs help to assure the quality and consistency of the services, and thus minimize harm to the patient. Types of SOP: Analytical method. Preparation of Reagent. For operating instruments, equipment and apparatus. Safety and Precautions. Receiving and registration of sample. Fundamental SOP.. presentation title

4. How to write an SOP:SOPs shall be written in a concise, step by step, easy to read. The information should not be complicated; it should be simple and short. Routine procedures those are short and require few decisions can be written using simple steps format. And the long procedures consisting of more than 10 steps should be written along with graphical format or hierarchical steps. Also, the procedures that require many decisions should be written along with flow chart. • Content of SOP: • • Company name and pagination. • • Title. • • Identification. • • Review and approval. • • Purpose. • • Scope. • • Responsibility. • • Procedure.

5. Sop Process:• SOP Preparation.• SOP Review and Approval.• Frequency of revisions and reviews. •Implementing SOP.• Management of SOP. presentation title

6. Quality AuditAuditing is defined as inspection of a process or a system to ensure that it complies with the requirements of its intended use ORQuality audit is a systematic and independent evaluation to determine the implementation of various activities and their compliance with the planned provisions and related results and to evaluate the suitability of these provisions to achieve the objectives.Hence, it is a systematic examination of a quality system. Generally there are two types of audit 1)Internal (First Party, Self) • This type includes audits by company employees, consultants and contractors 2) External Supplier Audit(Second Party) • Customer employee(s) audit your company or • Your employee(s) audit a company which supplies your company with a product or service presentation title

7. Reasons for quality auditing: • To determine the level of compliance.• build confidence in GMP and the QA system.• To create interdepartmental confidence, understanding, and communication.• Determine actions required for improvement, e.g., premises, equipment, environment, operations, actions, procedures.• Necessary for the personnel/training and it creates a stimulus for improvement and recommends corrective action.• Helps in monitoring the improvement. • Importance of quality audit: • To ensure the quality of the products. all manufacturers are required to establish and implement an effective pharmaceutical QA system. • To assess the effectiveness of these QA systems and to ensure it follows GMP, self-inspection and other regulatory audits must be performed. • Audits can be used to establish with a high range of confidence to remain adequate level of control by management. presentation title

8. Steps to perform a quality audit:- PLAN AND PREPARE FOLLOW UP ARRANGE & ANNOUNCE FORMAL REPORT WITH RECOMMENDATION ARRIVE AT SITE OF AUDIT MEET, EXPLAIN PURPOSE INFORMAL ORAL REPORT OF FINDINGS PERFORM AUDIT

9. Types of audit methods/techniques which are categorized based On the purpose of audit:1. Horizontal Auditing:It involves examination of each functional area of an organization.> Used for internal system auditing and second party assessment when it is necessary to establish if a basic Quality management system has been installed and is being implemented and maintained.> Each functional area is checked for conformance with quality system requirements, applicable to that area.2. Vertical Auditing:It involves examining functional areas of an organization that are actively contributing to a specific work package or contractual requirement.3. Random auditing:It examines the several aspects of operation in an organization as evaluated by auditor and there is a need to closely examine a particular actively or generally probe the system in a random manner. presentation title

10. Report Audit Finding:Audit reports should contains - complete details of program detectedCorrective actions taken to eliminate problemsThere are two important reporting phases-1) Preliminary reports during audit2) Final reports to the managements

11. thank you