STANDARD OPERATING PROCEDURE - VI SEMESTER B.PHARM

In this topic , it covers about standard operating procedure in pharmaceutical quality assurance. the SOP is a written set instructions describing step wise how a routine activity is to performed . In this topic comes under B.PHARM VI - SEMESTER SYLLABUS

1. Pharmaceutical quality assurance Presented by E.k.sastiga ( L.E)   VI semester – B.pharm KMCHCOP

2. SOP – Standard Operating Procedure Sop is a written set of instructions describing step wise how a routine activity is to be performed . Sop must be written by persons who have sufficient knowledge and experience with the task being described It should be carried out by simple language and cover all the major steps in performing the task It should be prepared by respective department and then reach QA for review for checking it it complies with GMP

3. Objectives   To describe the responsibilities of the coordinating center for managing and monitoring the participating sites To provide guidelines for accurate and timely data collection, resolution of data queries   To maintain  their quality control and quality assurance process .   To ensure compliance with governmental regulation  To provide a documental procedure for establishment of quality assurance in the organization      7/22/2025 3

4. SCOPE: To provide the guidelines for the proper implementation of quality assurance system. TYPES OF SOP : 1. Analytical method 2. Preparation of reagents    3.For operating instrument , equipment, and apparatus 4. safety and precaution 5. methodic 6. receiving and registration of samples  7/22/2025 4

5. SOP WRITING STYLE   Write concisely, clearly, and follow a step-by-step format   Write in the active voice and present the main idea first   Avoid ambiguity     Be careful around important terms:  The main terms here are "may," "must," and "should." Remember that using the word "may" gives personnel decision-making power and/or flexibility depending on the context. "Must," is always mandatory and "should" is by nature conditional.   Make smart use of formatting 7/22/2025 5

6. A Model Format for an Effective SOP The model described below lays out the components of an SOP in a way companies can adapt to their own needs and situations. Header:  This should include the title, document number and version. The header should clearly identify the activity in question and contain any relevant keywords. (1.0) Purpose:  The purpose should define the intent of the document and be no longer than one or two sentences. It needs to be detailed enough so end users can quickly recognize what the document covers with no other detail included. (2.0) Scope:  This defines to whom or what the particular set of procedures applies. Many SOPs cover only what is in scope without stating what is not in scope, however it may be appropriate to state both. Judge the completeness of your scope by asking yourself if what is written leaves anything for interpretation. If the answer is yes, there's likely more work to do. By clearly spelling out what and who is and is not in scope, you offer everyone the everyone to have the same starting point of understanding. 7/22/2025 6

7. (3.0) References and Related Documents:  Offer documents and references needed to understand and effectively execute the procedures in addition to other SOPs, or government-issued documents the SOP references. If you use a Master Reference Document, list the title and any identifying numbers for the referenced documents. If not, provide the entire reference cited and use the standard reference format for publishing. (4.0) Definitions:   Clarify any terms that may not be familiar to end users and spell out any acronyms or abbreviations that are used. Remember that while a term may be familiar to you, it may not be familiar to them. What's more, a clearly defined SOP can help regulators understand your procedure without requiring further investigation during an inspection 7/22/2025 7

8. (6.0) Procedure:  Remember that regulators work to hold companies to standards set forth in their written procedures if those standards and practices are necessary and capable of being maintained. The FDA wants to ensure that standards meet compliance expectations without containing so much material that it may actually create a compliance risk. To avoid this, break the procedure down into the following components. Major steps:  Your SOP should include only the steps necessary for accomplishing the objective of the procedure. Individual action steps within each major step Notes:  These should be provided separately and be given to offer information for clarifying the process and/or responsibilities and possible warnings 7/22/2025 8

9. (7.0) Appendices:  These typically work best as a flow chart to aid in explaining the procedures during and audit or for those who learn better visually. (8.0) Revision History:  Record the changes made to a procedure and justification or the reason why the procedure was created. Approval Signatures:  This is usually found on the cover or the back page. Some SOPs require various approval signatures. Key roles in play include the Author, Reviewer, Management Approver, and Quality Reviewer/Approver. It's important to note that Under 21 CFR Part 211, the quality control unit is required to approve all procedures that may impact “the identity, strength, quality, and purity of the drug product.” 7/22/2025 9

10. 7/22/2025 10 FORM OF SOP WRITING

11. SOP PROCESS 7/22/2025 11

12. SOP PREPARATION : The organization should have a procedure in place for determining what procedures or processes need to be documented.  Those SOPs should then be written by individuals knowledgeable with the activity and the organization's internal structure. SOPs should be written with sufficient detail so that someone with limited experience with or knowledge of the procedure, but with a basic understanding, can successfully reproduce the procedure when unsupervised 7/22/2025 12

13. SOP Review and Approval SOPs should be reviewed (that is, validated) by one or more individuals with appropriate training and experience with the process The finalized SOPs should be approved as described in the organization’s Quality Management Plan or its own SOP for preparation of SOPs Signature approval indicates that an SOP has been both reviewed and approved by management.  As per the Government Paperwork Elimination Act of 1998, use of electronic signatures, as well as electronic maintenance and submission, is an acceptable substitution for paper, when practical. 7/22/2025 13

14. Frequency of Revisions and Reviews SOPs should be also systematically reviewed on a periodic basis, e.g. every 1-2 years, to ensure that the policies and procedures remain current and appropriate, or to determine whether the SOPs are even needed.  The review date should be added to each SOP that has been reviewed. If an SOP describes a process that is no longer followed, it should be withdrawn from the current file and archived If desired, modify only the pertinent section of an SOP and indicate the change date/revision number for that section in the Table of Contents and the document control notation 7/22/2025 14

15. Checklists Many activities use checklists to ensure that steps are followed in order. Checklists are also used to document completed actions Any checklists or forms included as part of an activity should be referenced at the points in the procedure where they are to be used and then attached to the SOP.   In some cases, detailed checklists are prepared specifically for a given activity.  In those cases, the SOP should describe, at least generally, how the checklist is to be prepared, or on what it is to be based. Copies of specific checklists should be then maintained in the file with the activity results and/or with the SOP. Remember that the checklist is not the SOP, but a part of the SOP 7/22/2025 15

16. REFERENCE :   https://www.thefdagroup.com/blog/a-basic-guide-to-writing-effective-standard-operating-procedures-sops    https://www.epa.gov/sites/default/files/2015-06/documents/g6-final.pdf .   https://pharmablog.in/ https://en.wikipedia.org/wiki/Wiki . A Basic Guide to Writing Effective Standard Operating Procedures (SOPs)   A Basic Guide to Writing Effective Standard Operating Procedures (SOPs) 7/22/2025 16