Standard Operation Procedure (SOP)
- 1. STANDARD OPERATION PROCEDURE Set of written instructions that is followed routinely or repetitively Back bone of pharmaceutical industries. SOPs described both technical & fundamental programmatic operational element of an organization that would be managed under a works plan or a QA project plan. In simple terms SOPs is: - ✓ A written process ✓ A way for the clinical site to perform a task the same way each time is completed. Reason for having SOPs: - ❖ To provide people with all the safety, health, environmental, & operational information. ❖ To ensure that no failures occur in any processes. ❖ To ensure that approved procedure are followed in compliance with campnayy& government regulations. ❖ Provide training& guidance for new staff. FDAs three golden rules on proper documentation: - a. If it is not written down, if didn't happen. b. If it isn't written down properly, if didn't happen either. c. Don't forget rules 1 & 2. Position of SOP in total documentation: - ▪ 3rd layer in documentation ▪ 1st GLP & 2nd company policies. ▪ GMP OBJECTIVES: - 1) to describe the responsibility of the coordinating center for managing & monitoring the participating sites. 2) To details the regularly recurring work processes that are to be conducted or followed within an organization. 3) To facilitate consistent conformance to technical & quality system requirement & to support data quality. 4) To maintain their Qc & QA processes. 5) To ensure compliance with government regulations. 6) To serve as a training document for teaching users about the process for which the sop was written. BENEFITS: - a) Provide information to perform job properly. b) To provide people with all safety, health, environmental operational information necessary to perform job properly. c) Also provides consistency d) Minimizes variation & promotes quality, steps can be reviewed in accident investigation e) Serves as a training document for users. f) Sop's are useful tool for training new members of staff. g) Sop's give clarity to the pharmacy personal to follow steps & uniformly. h) Sop's helps to assure the quality & consistency of the services.
- 2. AREA OF SOP - Safety & precaution To deal with complaints Fundamental Analytical methods Preparation of reagents Methodic Instrument/ equipments & apparatus QA SOPS WRITTEN STYLES :- • SOPs shall be written in a concise, step by step, easy to read and follow format. • Information should not be complicated. The active voice and present verb tense should be used. • Should be simple and short. • Routine procedures that are short and require few decisions can be written using simple steps format. • Long procedures consisting of more than 10 steps, with few decisions should be written along with graphical format or hierarchical steps. • Procedure that enquiries many decisions should be written along with flow chart. INSIDE THE SOP: - 1. Company name and pagination -The company name and pagination (e.g. page 4 of 7) must appear on every page. 2. Title-The title should be descriptive. The title should use directive language to declare what is being done to what. 3. Identification-Procedures must be easily identified by giving unique number and version number. 4. Review and approval-All SOPs shall have space for signature of initiator (the person who has written the SOP) Reviewer (The persons who has reviewed the SOP) and approver (Quality Assurance Head of the organization). 5. Purpose-The purpose or objective of the procedure should restate and expand well written title. 6. Responsibility -Who is responsible for performing the work described? Who is responsible for implementing the procedure? 7. Procedure-Describe the procedure in a step by step, chronological manner. Use active verbs and direct statements. TYPES Of SOP’s
- 3. Master SOP:-In addition to the various SOPs that are required, the company has to first make an SOP that defines how the various SOPs will be made, i.e. what kind of information, structure and numbering system will be included in various SOPs. It should also contain a time frame for revision of SOPs. It should identify the persons authorized for each activity (creating, checking, verifying and implementing). SOPs PROCESS :- 1) Sop preparation- environmental personal, performs the job, equipment manufacturers, safety, technical initiation, performs maintenance 2) SOP Review and Approval- SOPs should be reviewed by one or more individuals with appropriate training and experience with the process especially help fulfil draft SOPs are actually tested by individuals other than the original writer before the SOPs are finalized. 3) Frequency of Revisions and Reviews- SOPs need to remain current to be useful. Therefore, whenever procedures are changed, SOPs should be updated and re-approved. 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. 4) Implementing SOP-The most important step for implementing the SOP is in working area, train or retrain the user. Everyone should follow the procedure exactly with each and every step in detail, it is very important to train the user otherwise individual may interpret meaning indifferent ways 5) Management of SOP-Organization shall have SOP on Preparation, approval, revision and control of standard Operating Procedure for better control and management of SOPs. SOP General Format:-SOPs should be organized to ensure ease and efficiency inuse and to be specific to the organization which develops it. Where possible break the information into a series of logicalsteps to avoid a long list.SOP generally consists of 1. Title Page-The first page or cover page of each SOP should contain the following information: a. A title that clearly identifies the activity or procedure b. An SOP identification (ID) number c. Date of issue and/or revision d. The signatures and signature dates of those individuals who prepared and approved the sop 2. Table of Contents:- • A Table of Contents may be needed for quick reference, especially if the SOP is long • To locate the information • To denote changes or revisions made only to certain sections of an SO 3. Text:- a. The purpose of the work or process b. The scope of the work or process c. Responsibilities and applicability’s d. Summary of the method/procedure e. Definition of any specialized/unusual terms and explanation of abbreviations. f. Health and safety cautions g. Attach any appropriate information, e.g., an SOP may reference other SOPs
- 4. Exmples of SOP SOP's for sterilization Dry sterilization- exposing materials to dry heat in hot air ovens. 160c for one hours.