T3A INDUSTRIAL

DOC # AP-05-1023 Issue # 01 Page 1 of 4

STANDARD OPERATING PROCEDURE

TITLE: CREATION OF PRODUCT DOCUMENTS

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
ISSUE # ISSUE DATE PAGE # SUMMARY OF CHANGE

T3A INDUSTRIAL
DOC # AP-05-1023 1.OBJECTIVE:
1.1.This SOP describes the procedure for creation of Product documents.

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2.SCOPE:
2.1.This SOP applicable for any product documents in T3A Industrial.

3.RESPONSIBILITIY:
3.1.R&D specialist or designee: Collecting the data, making a draft for Manufacturing Formula (MF), Processing Instructions (PI) and Bulk Bill of Materials (BOM). 3.2.R&D manager or designee: Reviewing and approval the MF, PI and Bulk or Finished Product Bill of Materials (FP BOM). 3.3.R&D Administrator or designee: coding of FP BOM, Routing of Bulk BOM for approval, delivering it to QA. 3.4.IPC Supervisor or designee: Preparation of Intermediate product specifications (IP specs) and Intermediate product analytical monograph (IP monograph). 3.5.QC finished product analysis Supervisor or designee: Preparation of Finished product specifications (FP Specs) and finished product analytical monograph (FP Monograph), 3.6.QC stability Supervisor or designee: preparation of accelerated and long term stability study for first three produced batches from the new formula. 3.7.QC MOH sampler responsible person or designee: taking the samples from first three produced batches from the new formula. 3.8.QC Manager or designee: Reviewing and approval of MF, Bulk BOM, FP BOM, IP Specs, IP monograph, FP specs and FP monograph. 3.9.Production Supervisor or designee: preparation of Batch Processing Record (BPR), 3.10.Packaging Supervisor or designee: preparation of Batch Packaging Record (BPkR), Packaging instructions (PkI) and FP BOM. 3.11.Production Manager or designee: reviewing and approval of PI, BPR, BPkR, PkI, Bulk BOM and FP BOM. 3.12.Production administrator or designee: Routing of FP BOM, BPR, BPkR and PkI for approval, delivering it to QA.
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T3A INDUSTRIAL
DOC # AP-05-1023 Issue # 01 Page 3 of 4

3.13.QA Documentation officer or designee: Receiving and reviewing of all product related documents, delivering all product related documents to QA manager for approval, distribution and archiving. 3.14.QA Validation officer or designee: preparation of validation Protocol for implementation in the first three batches form the product. 3.15. QA Manager or designee: Reviewing, approval and system compliance.

4.PROCEDURE:
4.1.R&D formulator shall: 4.1.1.Collecting the data about the new product and making required tests. 4.1.2.Prepare the new formula and the Bulk BOM. 4.1.3.Prepare the MF which contains the components and its quantities. 4.1.4. 4.1.5. 4.2. 4.3. 4.3.1. 4.3.2. 4.3.3. 4.3.4. 4.3.5. 4.4. 4.5. 4.6. 4.7. Prepare the PI which contains the procedure to be followed for processing and the parameters for IP specs if needed and FP specs. Attaches a stability study for the new formula and new PI. R&D Manager shall review and approve the new MF, PI and Bulk BOM before routing for approval by other managers. R&D Administrator shall: Routing the new Bulk BOM for approval by RA, IT, QC, Production and QA managers Routing the new MF for approval by QC manager. Routing the new PI for approval by Production manager. Coding and description for the new FP BOM for all registered markets for this product. Delivers the MF, PI, Bulk BOM the stability study for QA after approval from previous managers. IPC supervisor shall prepare the IP specs and IP monograph according to the data which included in the PI. QC FP Analysis supervisor shall prepare the FP specs and FP monograph according to the data which included in PI. QC stability supervisor shall take the samples from the first three produced batches for the accelerated and long term stability study. QC MOH sampler shall take the samples for MOH representative from first three produced batches from the new formula.
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T3A INDUSTRIAL
DOC # AP-05-1023
4.8. 4.9. 4.10. 4.11. 4.12.

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QC Manager shall Review and approve for IP Specs and monograph, FP specs and monograph and stability study. Production supervisor shall prepare the BPR according to the data which included in the MF & PI. Packaging supervisor shall prepare the FP BOM, PKI and BPkR for all registered markets for the product. Production manager shall review and approve the Bulk BOM, FP BOM, PI, PkI, BPR and BPkR before delivering it to QA. Production Administrator shall:

4.12.1. Routing the FP BOM for approval by RA, IT, QC, R&D and QA managers. 4.12.2. Delivering the BPR, FP BOM, PkI and BPkR for QA office for reviewing and final approval. 4.13. 4.14. 4.15. QA Documentation officer shall receive and review all product related documents and deliver it to QA manager for final approval. QA Validation officer shall prepare the validation protocol and implement it in the first three produced batches after approval from QA manager. QA manager shall review and approve all product related documents and insuring the compliance in the system.

5.
5.1.

ATTACHMENT:
N/A

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