BESTMEDICINE LABORATORY SOPNo WP6_Q_1001.3 Version No. 3 January21, 2018 AUTHORED BY: Kasturi Haldankar Name of Author Sign and Date REVIWED BY: Premchand Naik Name of Assistant Manager Quality Assurance Sign and Date APPROVED: Robert Mark Name of Quality Assurance Manager Sign and Date Anna Holland Name of Head of Quality Assurance Department Sign and Date I. Purposeand Applicability:Thisprocedure is a guidance on how to prepare, number, retain, index, revise andformat the Standard Operating Procedure (SOP) documents. This SOP is forauthors who write the SOPs.
II. Summary:Studymethods and procedures are described in detail in SOP to maintain the qualityand integrity of the data and processes. SOPs are created to provide step wiseguidance to the technical and administrative end users, reviewers and approversof their roles and responsibility to help them perform in a better way. Authoringof SOP in correct way is important. A SOP should follow a standard format forease of understanding throughout organization. III. Definitions: IV. Responsibility: 1.
Identifythe need of SOP by personnel in the department2. Informthe immediate supervisor of the department about the need of SOP3. Intimatethe Quality Assurance Manager the need of SOP4. Authorshould write the SOP in a way that all the steps to be followed are clearly mentionedin the SOP5. SOPshould be reviewed by one or multiple reviewers as required6.
Reviewersshould be directly related to the SOP or from department who may be affecteddue to the SOP being prepared. 7. Thedepartment in charge of SOP and QA manager should review the SOP. QA managershould assure that the SOP documents what are the actions to be followed when aSOP is not being followed correctly.8. QAmanager checks the uniformity and format of the SOP document and lifecyclemanagement of the SOP V. Procedure: a.
PreparingSOPs1. Identifythe need to make or revise a SOP and intimate immediate supervisor of the same.2. Authorthe SOP who is responsible for the procedure.3. Sendthe draft copy of the SOP to other individuals in the department who directlyrelated or involved in the procedure for their review.4.
Sendthe final draft SOP to QA manager for approval of the SOP.5. Formatof the SOP document should be the same throughout the document for font, fontsize, color, numbering and margins.6. Headershould mention the SOP no, SOP Title, Revision date, Supersedes, Effective Dateand Page no7. Thetitle page should include Names of author, reviewers and approvers along withsign and date.8. SOPdocument should have Table of contents with correct headings and numberings.
9. Section to be included in SOP are asbelow mentioned in Table 1. List ofSections to be included in SOPs: Table 1 List of Sectionsto be included in SOPs: Administrative SOPs Technical SOPs Purpose Yes Yes Summary of the procedure Yes Yes Definitions Yes Yes Responsibilities Yes Yes Qualifications Not required Yes Health and Safety Warnings Not required Yes Cautions Not required Yes Equipment and Supplies Not required Yes Procedure Not required Yes Data and Record Management Yes Yes Quality assurance and Quality Control Yes Yes References Yes Yes b. Numberingof SOP: 1. EachSOP belongs to a specific category maintained by the QA. Each SOP has uniquenumber assigned.2.
QAmanager determines the category to which the SOP belongs and assigns the numberto the SOP.3. Listof categories are Category 1000-1999 General and Administrative 2000-2999 Laboratory procedures 3000-3999 Validation of the Procedures 4000-4999 Lifecycle Management of SOPs 5000-5999 Record maintenance of Trainees 6000-6999 Miscellaneous c. Indexingthe SOP:1. Responsibilityof QA manager is to list the SOP in the main List of all SOPs in Quality datamanagement document/manual. d. RevisingSOPs:1.
Typoerrors will not be subjected to revision of SOP number.2. Changein procedure, addition or deletion to SOP will require full review of the SOPand approval and will be assigned a revised SOP number.3. Thedepartment in charge of SOP should request to eliminate the previous SOP beforemaking the revised SOP effective.4. TheSOP which are no more required should be archived for future references. e.
UsingSOPs1. Individualsdirectly related or departments affected due to change should trained wellbefore the effective date of the SOP.2. Trainingrecords should be maintained in a repository for future reference.
3. Allthe step wise procedure should be followed as mentioned in the SOP4. Anydeviation to the SOP should be documented.5. Justificationto SOP deviation should be provided to QA.6. Correctiveaction plan should be executed.
VI. Managementof Recorda. Locationof SOP1. Allapproved signed SOPs belonging to the department should be placed in the SOPdrawer belonging to the QA manager.2. SOPdrawer should be allowed to use by the QA manager and QA Head of the Departmentonly.b. SOPRetention:1.
Originalsigned SOP and its other revised SOPs are archived and maintained by QA manager.2. Ifa new procedure is incorporated into another SOP a copy of superseded versionis also included in the binder on the archived SOP. VII. QualityAssurance and Quality Control1. Reviewthe SOP every 3 years to update any information which needs modification.
2. SOPswhich do not require any change should be justified to QA and approval for thesame is to be received. VIII.
Reference1. Quality Manual of BESTMEDICINE LABORATORIES Version 3.12. Guidancefor Preparing Standard Operating Procedures (SOPs) EPA QA/G-6 IX. RevisionRecord: SOP No. Revision Date Description of change Responsible person A-1001.1 01/15/2016 Initial Release John Smith A-1001.2 03/05/2017 Editorial changes and typo errors changes performed Joh Smith