Concept of sop

Concept of SOP in Pharmaceutical organization

1. What is SOP? Standard Operating Procedures  (SOPs) are issued to specifically instruct employees in areas of responsibility, Work Instructions, appropriate specifications and required records. SOPs outline procedures, which must be followed to claim compliance with GMP principles or other Statutory rules and regulations . OR A Standard Operating Procedure (SOP) is a certain type of document that describes a step-by-step outline form on how to perform a particular task or operation. same procedures must be followed to assure that tasks are performed consistently and correctly

2. SOP The procedure for describing the writing, revising and approving of SOPs and the control of distribution of SOPs is one of the important Quality Assurance procedure. “Quality is everyone's responsibility” W. Edwards Deming

3. Purpose of SOP [ SCHEDULE M] [See Rules 71, 74, 76 and 78] • GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES, PLANT AND EQUIPMENT FOR PHARMACEUTICAL PRODUCTS. • PART 1 : Good Manufacturing Practices For Premises And Materials • PART I-F : SPECIFIC REQUIREMENTS OF PREMISES, PLANT AND MATERIALS FOR MANUFACTURE OF ACTIVE PHARMACEUTIAL INGREDIENTS (BULK DRUGS)

4. Purpose of SOP 21 CFR Part 211 : Current Good Manufacturing Practice For Finished Pharmaceuticals Subpart F 211.100 Written Procedures and Deviations “(a) There shall be written procedure for production and process control designed to assure that drug product have the identity, strength, quality and purity, they purport or are represented to possess.” (b) Written production and process control procedures shall be followed in the execution of the various production and process control functions and shall be documented at the time of performance. Any deviation from the written procedures shall be recorded and justified.

5. Purpose of SOP 21 CFR Part 280 : Sec. 820.40 Document controls. Sec. 820.70 Production and process controls. Sec. 820.80 Receiving, in-process, and finished device acceptance. “Firms must “establish and maintain” procedures . To do so, companies should define, document (either on paper or electronically), and implement standard operating procedures (SOPs). Additionally, companies must then follow up, review, and revise these documents as needed.“

6. Purpose of SOP ISO 9001- 2008, Clause 4.2 : Documentation requirements “Documented procedure”, has to be established, documented, implemented and maintained.” • IS/ISO 14001 : 2004 , Clause 4.5.4 : Control of records “ The organization shall establish, implement and maintain a procedure(s) for the identification, storage , protection, retrieval, retention and disposal of records.” • IS 18001 : 2007 , Clause 4.4.5 : Control of Documents “ The organization shall establish, implement and maintain a procedure(s) for the Controlling all documents required by the OH&S management systems and by this standard.” • ICH Good Manufacturing Practice Guide for API Q7 , Section 6 Documentation and Records “ All documents related to the manufacture of intermediates or APIs should be prepared, reviewed, approved, and distributed according to written procedures. • EudraLex Volume 4: Chapter – 4 Documentation

7. Benefits of SOP To perform a job properly. 2. To ensure that concerned department (e.g. Production/QC/EMD) operations are performed consistently 3. To ensure that processes continue uninterrupted and are completed on a prescribed schedule 4. To ensure that no failures occur in manufacturing and other processes for which the SOP was written 5. To ensure that approved procedures are followed in compliance with company and government regulations

8. Benefits of SOP 6. To serve as a training document for teaching users about the process. 7. To serve as a checklist for co-workers who observe job performance to support proper performance. 8. To serve as a checklist for auditors. 9. To serve as an historical record for the Change over. 10. Organization becomes system oriented

9. SOP Preparation • Should be written by individuals knowledgeable with the activity and subject-matter experts. • By an individual who performs the tasks routinely or someone who is directly responsible for the performance of the task like… √ Those who will perform the job √ Those who will perform maintenance on equipment involved in an SOP √ Engineers or others who design equipment and processes √ Technical initiator √ Safety personnel √ Environmental personnel √ Equipment manufacturers

10. Typical Structure of SOP The content of a Standard-Operation-Procedure should include the following minimum • Title page • Organization Logo • Header with title of SOP • Department Name • Effective date • Revision date • Review date • Page No • Regulatory basis / Reference • Reference documents / Annexure / Attachment • Purpose • Scope • Responsibilities & accountabilities • Procedure • Footer Approving Signatures √ Prepared by √ Checked by √ Approved by • Stamp √ Controlled Copy/Master Copy √ QA Stamp

11. SOP Review & Approval Review period for the GGC Document is 3 years. • SOP review will focus on the document’s content, context, format and grammar. • Review factors and criteria are : √ Adherence to standards √ Consistency and traceability √ Readability, comprehensibility, and general understandability √ Technical adequacy and feasibility of approach √ completeness √ Testability of requirements √ Use of appropriate requirement, design, or coding techniques √ Appropriate level of details

12. SOP Revisions Routine revision • At the end of the review period. Concerned HOD particular SOP will review and revise if required. • If there is no change then HOD just give the review report, this SOP doesn’t require review and continue the same for the next review period. During the review period revision • By the process owner with the approval of the HOD, fill up the CC form and SOP will be revised with new revision and effective date. • As per the same Previous version will be Superseded or Obsolete. Final approval of the any type of the change in the SOP is given only by the QA department

13. Implementing SOP The most important step for implementing the SOP in working area, train or retrain the user. • While training the user, trainer should share the reason WHY, SOP must performed correctly. • People are much more to follow when they understand importance of procedure. • Trainer should explain and demonstrate how each step in the SOP will be performed and should assure them this will increase Quality of product by providing safety and accuracy which will ultimately increase the confidence of the user

14. Management of SOP There should be the record for issue and distribution of the SOPs. • It is the responsibility of the process owner to √ Ensures that SOPs are current. √ Eliminates obsolete SOPs. √ Ensures that SOPs meet their quality requirements and are user friendly. √ Manages SOP change controls. √ Distributes SOPs. √ Ensures that new or changed SOPs are valid only after training has occurred and provides training about the SOP system. √ Measures system performance and periodically reports results to management √ Continuously improves the system.

15. Guidelines WHO guidelines Food and Drug cosmetic act 1940 Schedule M ICH guidelines ( International conference on harmonization ) ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE (APIC) Guideline PIC/S Guideline 21 CFR Part 211 EMEA guidelines Regional Recommendations

16. Thank You Arti Sindhav