d"'<--'''''\ Document No. TITLE SOP for SOPs Effective Date 01,08,2015 c..-"f.(l1'{~ Page No, I or8

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1 CENTRAL DRUGS STANDARD CONTROL ORGANIZATION, DGHS (I d"'<--'''''\ \ Document No. cosec '. cosco Revision No. 02 \, --l TITLE Division Name Quality Assurance QA-GNL-OI Effective Date 01,08,2015 c..-"f.(l1'{~ Page No, I or8 Prepared By Approved By Authorized By Name Mr. Rakesh Negi Name Mrs. Rubina Bose Name Dr, G, N, Singh Designation Drugs In~,! tor Designation DDC(I) Designation r JCG(I) Sign Y",lH\N"'t Sign f-i!>ri>- Sign \ fu"" Dale y 2.1\01 h~ Dale '/-115 Date ;H10"lll :> Control Status 1.0 Purpose To lay down a procedure for the preparation, approval and control of Standard Operaling Procedures (SOPs), 2.0 Scope This document is applicable to all Standard Operating Procedures of all Divisions of Central Drugs Standard Control Organization, 3.0 Responsibility 3.1 The ADC (I) / DDC(I)of concerned Divisionshall be responsible for preparation of the SOP. 3.2 JDC(I) shall be responsible for Approving the SOP. 3.4 DCG(I)shali be responsible for Authorizing of this SOP. 4.0 Accountability Head of QA&Drugs Controller General (India). 5.0 Procedure 5.1 All the SOPs shall be prepared as per the current version of Annexure-I (QA-GNL OOI/FOI). 5.2 All SOPs shall be written in clear and easy to understand language. 5.3 All SOPs shall be printed on standard A-4 size paper ofappropriate quality in black ink. 5.4 All SOPs shall have the following parts as: Formal No. QA-GNL-OOI/FOI-OI

2 CENTRAL DRUGS STANDARD CONTROL ORGANIZATION, DGHS TITLE Division Name Quality Assurance Document No. QA-GNL-OI Revision No. 02 Effective Date Page No. 20f8 Prepared By Approved By Authorized By Name Mr. Rakesh Negi Name Mrs. Rubina Bose Name Dr. G. N. Singh Designation Drugs ll)$p<;qtor Designation DDC(I) Designation f\dcg(i) Sign Sign Sign Date Dale Date i A) Header CENTRAL DRUGS STANDARD CONTROL ORGANIZATION DGHS Authorized Personnel Onlv On the left. hand corner FontType: Times New Roman Fontsize: 10 I CDSCO Logo On the len hand of table TITLE In the center, Bold FontType: Times New Roman Font size: 12 Division Name Document No. Effective Date Revision No. Paze No. Prcoared Bv Acnroved By Authorized By Name Designation Sian Date B) Body Headings Numbered by n Subheadings Numbered by n Body part contain Purpose, Scope, Responsibility, Accountability, Font Type: Times New Roman Procedure, Annexure I Format, References, Abbreviation, Revision H istorv Font size: 12 C) Footer Formal No. FontType: Times New Roman Font size: A unique title shall be given to each SOP. The title shall indicate the purpose of SOP very clearly and briefly No titles shall be duplicated for other or different SOPs. 5.6 All the SOPs shall have a unique number consisting of 10 alphanumeric characters as: XX yyy-zzz Where, XX Division Code. Format No. QA GNL-001/FOI-01

3 CENTRAL DRUGS STANDARD CONTROL ORGANIZATION, DGHS ll\..,~,~~ TITLE Division Name Quality Assurance Document No. QA-GNL-Ol e CDSC~ "CDSC~ Revision No. 02 \ '"", I Effective Date "-litlft,(AIl.~ Page No. 3 ors Prepared By Approved By Authorized By Name Mr. Rakesh Neg; Name Mrs. Rubina Bose Name Dr. G. N. Singh Designation Drugs l""pe,<;tor Designation oocm Designation. I CO(I) Sign (11 \..If' Sign ~-- Sign \\,IW Date ~'\O'\I<: Date :26'1 Dale :wi.,,, <' 7 \ IS Dash/Separator YYY Group Code Dash/Separator ZZZ Sequential no. starting from 00 l....n In the SOP No. following division codes shall be used: Division name Division Code Quality Assurance division QA Technical division TD In the SOP No. following group codes shall be used: Group name Group Code Description General GNL SOPs referring general processes of various divisions Import License IML Specific SOPs pertaining to lmport license Registration certificate RCD Specific SOPs pertaining to registration Certificate for import ofdrugs such as Pharmaceuticals, Medical devices, Vaccines, Diagnostic kits & Blood & blood product License to manufacture drugs LMD Specific SOPs pertaining to license to Manufacture drugs Clinical trial permission CTP Specific SOPs pertaining to approval of new Drugs and clinical trial applications Summary product characteristics SPC Specific SOPs pertaining to summary product Characteristics Marketing authorization MKA Specific SOPs pertaining to market Authorization Post marketing Activities PMA Specific SOPs pertaining to post marketing Format No. QA GNL-OOI/FOI-OI

4 CENTRAL DRUGS STANDARD CONTROL ORGANIZATION, DGHS fl',i"<'-''\ CDSW. I cosec \ '"!i; l Effective ~"',,""""'",TITLE Division Name Quality Assurance Document No. QA-GNL-OI Revision No. 02 Dale Page No, 4 or8 Prepared By Approved 0)' Authorized By Name Mr. Rakesh Negi Name Mrs. Rubina Bose Name Dr. G. N. Singh Designation Drugs Jn~pe,tor Designation DDC(J) Designation ( DCG(I) Sign (\).\~I Sign m«: Sign \ Jltw Date II-""" ~-i\0'1 \ \C Dale 2elol1 IS' Dale ~o1lr{ Activities.. inspections INS Specific SOPs pertaining to GMP and GCP Inspections. Pre-Screening of Application PSA Specific SOP pertaining tol-re-screening of Application For Example the first General SOP of Technical Division shall be assigned the no. TD-GNL-OOl 5,7 Contents of SOP The contents of the SOP shall be written under the following heads: 5,7,1 Purpose State the purpose for writing or performing any procedure, process or lechnique. 5,7,2 Scope Indicate when and where this procedure, process or the technique is applicable and needs to be performed. 5,7,3 Responsibility Mention' the designation of the person/s of the concerned division responsible for the execution, supervision and compliance of the relevant SOP. In the absence of the designated person, his I her designee shall be responsible. 5,7.4 Accountability Mention the designation of the person/s that is overall accountable (Head of QA I divisional Head & DCGI). 5,7,5 Procedure Give clear and step by step instructions on how to perform the procedure, process or any technique. Also mention the preliminary steps that shall be done before beginning the actual procedure. Subheadings as safety considerations, precautions, acceptance criteria etc., if any than it should be included under this heading. It shall be written in instructive form in chronological order with steps referred to by numbers, for the personnel to follow. Formal No. QA-GNL-OOlfFO 1-0I

5 CENTRAL DRUGS STANDARD CONTROL ORGANIZATION, DGHS I #1' I TITLE! - 1'~ cosec :,CDSCO, ~ "-, '. 3 "-..,.... _. l I 0,..~'<~ll);:(,O'It~"~"*' Prepared By Approved By Name Mr. Rakesh Negi Name Mrs. Rubina Bose Designation Drugs h\sne-c1or Designation DDC(I) Sion \~,\...\1\),-' Sign c---"- Date I Date :l-os 10, Ii s I, l",\ ls Annexure / Format " '-'-~..::..::.::.C.._---'---'-'-==:-=-=-=-=~ fi..4.rl»: --, ~---- Division Name Document No. Quality Assurance QA-GNL-Ol Revision No. 02 Effective Date Page No.. 5 of8 Authorized B.r Name Dr. G. N. Singh Designation ( DCG(1) Sign \.~ Date ~lo7lf{ All the Annexure / Format for SOPs shall be prepared as per the current version of Annexure-2(QA-GNL-OO I/F02) Mention the Annexure / formats where the results shall be recorded. Each Annexure / formats shall be assigned a number having 17 alphanumeric characters as: XX-YYY-ZZZ/FAA-BB Where, xx YYY ZZZ Division Code Dash/Separator Group Code Dash/Separator Sequential no. starting from 00 l...n / Dash/Separator FAA BB F (Format) AA (Sequential no. starting from Ol....n) Dash/Separator Revision no. of format, starting from OO...n) For example the first format ofthe SOP QA-GNL-OO Ishall be assigned a number as QA-GNL-OO I/FO References Mention the references ofdocuments! SOPs which are referred during SOP preparation Abbreviation Describe the abbreviations, terminologies (if any) used in the relevant SOP Revision History Mention the details in following table. Reasonts) for Revision ~ Revision ~ '-"==~'-""--="-"'='------ll - -~ I I I. Format No. QA-GNL-001!FOI-0 1

6 CENTRAL DRUGS STANDARD CONTROL ORGANIZATION, DGHS /"'1'\ /i... w.wto..r~ TITLE Division Name Quality Assurance l ~,.~ Document No. QA-GNL-Ol cosec cosec Revision No. 02 '" '\. ;,;.,;;0; _ of".," Effective Date 'lo""<llh,(;(joi<,,:..,-t Page No. 6 of8 Prepared By Approved By Authorized By Name Mr. Rakesh Negi Name Mrs. Rubina Bose Name Dr. G. N. Singh Designation Drugs Inspeetor Designation DDCO) Designation ( OCG(I) Sign ".~ I til. \V Sign Sign lw Date... Date 2&1 0711> Date M;j~7/,!' 2:1\01\ Ic If the SOP is new, write 'New' under the reason for revision. When there is a modification / revision in this SOP, the term 'New' shall be replaced with the reason for the revision / modification of the SOP. 5.8 Preparation and Review of SOPs Drugs Inspector / ADC (I) of concerned Division shall prepare the DRAFT SOPs for any procedure The DRAFT SOP shall be checked by Head of the division and the same shall be forwarded to QA for review QA shall review the DRAFT SOP and comment for any suggestion or change and send back the SOP to concerned division to change the SOP After discussion the Drugs Inspector / ADC (I) of concerned division shall change the SOP and take final printout and submitto QA after signing the SOP in respective columns of all pages QA personnel shall sign the SOP in respective columns and send back to concerned division for training of SOP After imparting the training to concerned personnel, the SOP shall be sent to QA to make it effective with the training record After verifying the same the QA personnel shall write the effective date and review date on each page of SOP. Note: Any SOP shall be made effective only after completion of required training and effective date shall be filled in respective column QA personnel shall keep the master copy having original signatures with QA and issue the controlled copies to respective division for their references as per the current version of SOP of document control procedure (QA-GNL-024) All SOPs shall be reviewed once in two years. Accordingly review date column shall be filled. The revision ofthe SOPs can be done even before two years on need basis. Format No. QA-GNL-OOI/FOI-Ol

7 CENTRAL DRUGS STANDARD CONTROL ORGANIZATION, DGI IS "," -,~Cbi,' cesc? " ~CDSCO \= / Effective (~,.\ TITLE Division Name Document No. Quality Assurance QA-GNL-OI Revision No. 02 Date ~~.-.:...(~~.f' Pace No. 70f8 Prepared By Approved By Authorized By Name Mr. Rakesh Negi Name Mrs. Rubina Bose Name Dr. G. N. Singh Designation Drugs Inspector Designation DDC(I) Designation pcg(i) Sign Sign Sign Dale...-~., \01 \( Date 2.!SID1 \ I S Date r~/o-,lrf \1.iliN~ :tf' P-fVIr- Lw Any change in a SOP / Annexure / format shall be done through the current version of SOP of change control (SYS-P-O 1) If a reference of any SOP / annexure / format no. is to be given in any document, it shall follow the 'current version of the same For all SOPs a SOP Index shall be prepared as per current version of Annexure-3(QA GNL-OO I/F03) and numbered as: XX-NN Where, xx Division Code Dash/Separator NN Sequential no. starting from 01...n For example the first SOP Index of the QA division shall be assigned a number as QA-OI 6.0 Annexure / Format AnnexurelFormat No. 7.0 References NIL Annexure - 1 Annexure - 2 Annexure Abbreviation i SOP ADC (I) Acronym Format for 'SOP' Title Format for' Annexure/ format' Format for 'SOP Index' Full Form Standard Operating Procedure Assistant Drugs Controller (India) Format No. QA-GNL-OOIIFOI-Ol

8 CENTRAL DRUGS STANDARD CONTROL ORGANIZATION, DGHS fl\ ji"''''':'.... TITLE Division Name Quality Assurance Document No. QA-GNL-OI CDSC?',,CDSCO Revision No. 02 SOP for SOl's Effective Date \ '- l Q...4iI"~ Paae No. 80f8 Prepared By Approvcc By Authorized By Name Mr. Rakesh Negi Name Mrs. Rubina Bose Name Dr. G. N. Singh Designation Drugs lnsp ctcr Designation DDC(I) Designation DCG(I) Sign ~J...\J1\' Sign...- or Sign ~ Dale l-"'"~., \ 01\ 1< Dale IS' Dme 'xt.7!1{ 9.0 Revision History Revision No. Reason(s) for Revision 00 New SOP 01 Revision of SOP format 02 Revision of SOP format Formal No. QA-GNL-OOllFOI-OI

9 "'..,:."""""~ ~c \ Annexure-l ofqa-gnl-ool Formal for 'SOP' { ~I Central Drugs Standard Control Organization ~(DSC~j~O~ Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India \ :...-.' FDA Bhavan, ITO, Kctla Road. New Delhi ",.t_~ CENTRAL DRUGS STANDARD CONTROL ORGANIZATION. DGHS /-... r 1\ \osr.~i~w:'..."'../ TITLE Division Name Document No. Revision No. Effective Date Page No. I of2 Prepared By Approved By Authorized B)' Name Name Name Designation Designation Designation Sign Sign Sign Date Date Date IL Control Status 1.0 Purpose 2.0 Scope 3.0 Responsibility 4.0 Accountability 5.0 Procedure 6.0 Annexure I Format AnnexurelFormat No. Title 7.0 References Doc. No. Title Format No. QA-GNL-001/F01-01 Page lof2

10 Annexure-l ofqa-gnl-ooi Format for 'SOP' Central Drugs Standard Control Organization Directorate General of Hcalrh Services. Ministry of Health and Family Welfare, Government of India FOA Bhavan. ITO. Kolla Road, New Oelhi Jr---- Abbreviation Acronym - Full Form 9.0 Revision History Revision No. Reason(s) for Revision Format No. QA-GNL-OOI/FOI-OI FOrmal No. QA-GNL-OOI/FOI-OI Page 2 of2

11 Annexure-2ofQA-GNL-OOl Format for 'Annexure / Format' " I/' ~~m -'~"\, ' I Central Drugs Standard Control Organization 0" ; \ --. FDA Bhavan, ITO, Kotia Road, New Delhi ~ cosec iti rnscc Directorate General of Health Services, Ministry ofheallh and Family Welfare, Government cf lndia...""...,~ Annexure No. of SOP No. 'Annexure / Format Title' Central Drugs Standard Control Organization Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India FDA Bhavan, ITO. Kalla Road, New Delhi Formal No. As per SOP format numbering system Page 1 of 1 Form'INo, QA-GNL-00IIF02-00 Page I of I

12 Annexure-3 ofqa-gnl-ool Formal for 'SOP Index' Central Drugs Standard Control Organization Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India FDA Bhavan, ITO, Kotla Road, New Delhi Annexure-3 ofqa-gnl-ooi 'SOP Index' Central Drugs Standard Control Organization Directorate General of Health Services, Ministry ofl-lealth and Family Welfare, Government of India FDA Bhavan, ITO. Kotla Road. New Delhi SOP Index for!division Name) SOP Index No. XX-NN Sr. No. SOP Title SOP No. Effective Date. Formal No. QA-GNL-001/F03-00 Page I of 1 Forrnatlvo. QA-GNL-001/F03-00 Page 1 of J

NAMIBIA MEDICINES REGULATORY COUNCIL MINISTRY OF HEALTH AND SOCIAL SERVICES

1 NAMIBIA MEDICINES REGULATORY COUNCIL MINISTRY OF HEALTH AND SOCIAL SERVICES FEES PAYABLE TO THE REGISTRAR (Regulation 47) 1. In respect of an application for registration of a Category A medicine - (a)