T3A INDUSTRIALDOC # AP-05-1022 Issue # 01 Page 1 of 7 STANDARD OPERATING PROCEDURE TITLE: GOOD DOCUMENTATION PRACTICE ISSUE DATE: …/…/…. EFFECTIVE DATE: …/…/…. REVISION DATE: …/…/…. ASSIGNEE PREPARED BY REVIEWED BY APPROVED BY NAME MOHAMMED ELASSADY MOHAMMED ELSAADY AHMED SALAH TITLE QA OFFICER QA SUPERVISOR QA MANAGER SIGN./DATE HISTORY OF CHANGE PA G E # ISSUE # ISSUE DATE SUMMARY OF CHANGE …………………. approval and system compliance. distribution and archiving.2.QA Manager or designee: Reviewing..1. analytical monograph. circulation of draft.Preparation of testing instructions.PROCEDURE: 4.This SOP describes the procedure for good documentation practice. Environmental management system manual. making a draft. protocols. plans.Quality assurance officer or designee: Receiving of the master documents.4. reviewing. organizing all raw data available.1. Document approval procedure. 4. 3.1. 3. protocols.Originating department initiator: Collecting the data. work instructions.1.1. delivering to QA manager for approval.. 4.Digit “2” of document number denotes the type of document as follow: Instruction Plan Protocol Program Analytical monograph (methods of analysis) Checklist 4.2. 3. Issue # 01 Page 2 of 7 2. and Organogram. programs. Quality manual.1. re-Issue procedure and format requirements: Refer to the standard operating procedure "creation of standard operating procedure". Specifications. APPROVED BY: ………………. preparation. This SOP applicable for preparation of testing instructions. programs and plans: 4.3. Subtitles that are common as follow: I L R G M H _____________________________________________________________________________________________________ PREPARED BY: ……………………… REVIEWED BY: …. site master file.… . analytical monographs. work instructions. Hazard analysis and critical control points [HACCP] management system manual.SCOPE: 2. make the corrections if needed and delivering it to Quality Assurance Officer.T3A INDUSTRIAL DOC # AP-05-1022 1. 3.RESPONSIBILITIY: 3.3.Department manager or designee: Reviewing the master document before delivering it to quality assurance department.OBJECTIVE: 1.1.1. Subtitles are common as follow: For product specification: • Product name • I.2. 4.D.………………….. re-Issue procedure and format requirements: Refer to the standard operating procedure "creation of standard operating procedure".2.3.2. Preparation of specifications: Document approval procedure. PROCEDURE: Describes the steps of procedures and the person(s) involve in carrying them out 5. and/or departments that this procedure applies to..1. 4. APPROVED BY: ………………. 3. Digit “2” of document number shall be "S". RESPONSIBILITY: Describes the responsible persons for execution this procedures. areas.2. SCOPE: Describes the sites.2.3.1.… Issue # 01 Page 3 of 7 . • Stage • Manufacturing formula # • Description • Sampling procedure • Qualitative and quantitative requirements and acceptance criteria • Storage conditions • Shelf life • Analytical monograph # • Qualitative and quantitative requirements and acceptance criteria _____________________________________________________________________________________________________ PREPARED BY: ……………………… REVIEWED BY: …. OBJECTIVE: Describes the task that this procedure covers and what is accomplished or produced when the procedures is successfully completed 2.T3A INDUSTRIAL DOC # AP-05-1022 1. 4. plants. 4. 4. ATTACHMENT: List all of items that are attached 4. No.2. 3.… .3.T3A INDUSTRIAL DOC # AP-05-1022 Issue # 01 Page 4 of 7 • Attachments (Certificate of analysis) 4.3. For packaging material specification: • Packaging material name • T3A identification Code _____________________________________________________________________________________________________ PREPARED BY: ……………………… REVIEWED BY: ….…………………..2.2..2. APPROVED BY: ………………. For starting material specification: • Synonyms and brand names • Molecular Formula • Molecular weight • Material code • Sampling Plane • Sample Size • Handling Hazards • Analytical Monograph • Qualitative and quantitative requirements and acceptance criteria • Storage conditions and precautions • Supplier • Supplier Code • Manufacturer • Retest Date • Shelf life • Packaging unit • Package type • Supplier Quality Performance • References • Products in which the material is used • Attachments (Certificate of analysis) 4. 3.5. resource management.………………….4. scope of activities.3. contract manufacturing& analysis.T3A INDUSTRIAL DOC # AP-05-1022 • Storage conditions • Approved Supplier • Sampling plan and procedure • Analytical monograph • Re-test date • Shelf life • Supplier Guarantee • Acceptance criteria • Attachment o Certificate of analysis o Approved design 4. 4. distribution. T3A in Brief. Site master file shall be succinct and as far as possible. 4. Site master file shall be reviewed yearly. documentation system. 4.. Site master file shall have an issue number and an effective date.3.3. product realization and measurement..3.1. quality system requirement.2. _____________________________________________________________________________________________________ PREPARED BY: ……………………… REVIEWED BY: …. APPROVED BY: ………………. personnel organization& qualification.3. 4. not exceed thirty A4 pages.4.4. management responsibility.2.Preparation of Quality manual: .4. acceptance criteria and reference and shall be signed by the QC analyst and QC manager. Site master file shall include general information about the firm. 4. complaints& product recall procedures and Self inspection procedure.Preparation of site master file: 4.1. 4.3. quality control system& activities. Quality manual shall have an issue number and an effective date.… Issue # 01 Page 5 of 7 4. Simple plans.4. outline drawings or schematic layout shall be used instead of narrative.2. analysis and improvement. production procedures& capabilities. The certificate of analysis shall be as a table include test. 4. premises& equipments for manufacturing& services. Quality manual shall include introductory pages. .2.………………….3. training awareness& competence. monitoring and measurements. monitoring& measurement.5. 4.2.5. 4. environmental aspects& safety risk& hazard control. corrective actions. 4.5.6.1. an issue number and an effective date. 4.6.7. Issue # 01 Page 6 of 7 Quality manual shall be reviewed yearly. HACCP management system manual shall be reviewed yearly.T3A INDUSTRIAL DOC # AP-05-1022 4.3.6. Organogram shall be initiated for each department. operational control. environmental& health& safety objectives & targets. Environmental management system manual shall have an issue number and an effective date. communication& consultation. Organogram shall be in a hierarchy form which describes the relation between the different positions in each department. recall procedure. organizational structure& responsibility. management review and record of revisions. training & awareness and competence.3.. APPROVED BY: ………………. document control.1. HACCP management programs. 4. non conformance& corrective& preventive action. environmental& health& safety management system documentation. records and record managements. document control. legal& other requirements. 4. 4. HACCP management system manual shall include T3A HACCP policy. communication & consultation. emergency preparedness& response.7.7. Environmental management system manual shall be reviewed yearly. 4. _____________________________________________________________________________________________________ PREPARED BY: ……………………… REVIEWED BY: ….2. environmental& health& safety management program. HACCP control. organizational structure and responsibility. Environmental management system manual shall include environmental& health& safety policy. environmental& health& safety management system audit. Digit “2” of document number shall be "O". 4. 4.6. HACCP system verification and record of revision.7.Preparation of HACCP management system manual: 4. Preparation of organogram: Organogram shall have a unique document number. records.7.4.4.Preparation of Environmental management system manual: 4. HACCP management system documentation. 4. operational control.1.… . HACCP objectives and targets.5. HACCP management system manual shall have an issue number and an effective date.3. T3A INDUSTRIAL DOC # AP-05-1022 4. 5..8. ATTACHMENT: NA _____________________________________________________________________________________________________ PREPARED BY: ……………………… REVIEWED BY: …..… .…………………. APPROVED BY: ………………. Issue # 01 Page 7 of 7 Factory Formats list: Refer to standard operating procedure "creation of standard operating procedure".