Follow
Objective: To provide a written procedure for handling and disposition of materials sourced from existing as well as new supplier.
Scope: This SOP shall be applicable for Quality Control Department.
Associated Documents
1. Receipt of Samples at Quality Control Laboratory
2. Accelerated Stability Study
3. Laboratory Notebook
Responsibility/Accountability
1. All QC personnel shall be responsible for handling and disposition of sourced materials.
2. Manager, Quality or his or her Designee shall be accountable for training and implementation of the procedure.
5.0 ABBREVIATIONS AND DEFINITIONS
5.1 Raw Material
Active Ingredient A substance or compound that is intended to be used in the manufacture of a pharmaceutical product as a pharmacologically active compound (ingredient).
Excipient Any ingredient other than the active ingredient added to a pharmaceutical product to permit it to be formed into the proper shape and consistency; the vehicle for the pharmaceutical product.
5.2 Packaging Material
Primary Packaging Material Any packaging materials coming into direct contact with a drug product.
Secondary Packaging Material Any packaging materials other than primary packaging materials. These could be either plain or printed.
5.3 Sourced Material The representative sample provided by a supplier to assess the quality of a raw or packaging material.
5.4 PD – Product Development
Precautions: Not applicable.
Procedure
7.1 QC shall provide the Buyer’s Specification to Purchase Department for sourcing raw material. The sourced material shall be collected according to the Buyer’s Specification by the Head of Purchase and forwarded to the concerned departments.
7.1.1 He shall collect sample of sourced raw material with Certificate of Analysis (COA), Method of Analysis (in case of non compendia), Material Safety Data Sheet (MSDS), Stability Data and Working Standard (if required) from the short listed suppliers.
7.1.2 In case of sourced active(s) used for manufacturing product for regulatory market, technical package, DMF (Drug Master File), EU GMP Certificate of the Manufacturer, Letter of access from the manufacturer for Beximco, Certificate of Analysis (COA) and BSE/TSE statement from the manufacturer shall be collected. The BSE/TSE statement shall also be collected for all excipients used in the product.
7.1.3 He shall collect sourced samples of primary packaging material with Certificate of Analysis (COA), Method of Analysis (in case of non compendia) and Material Safety Data Sheet (MSDS)/ secondary packaging material without COA from the short listed suppliers.
7.1.4 In case of sourced primary packaging materials (bottles, nozzles, caps) used for manufacturing product for regulatory market, drawing of the primary packaging materials, description of the used plastic materials, description of the sterilization of the primary packaging materials, validation document of the sterilization of primary packaging materials and Certificate of Analysis (COA) shall be collected.
7.2 In case of new Product, the material along with the necessary documents shall be send to PD Department. PD Department shall forward the samples along with the copy of all necessary documents to QC for analysis, evaluation and source approval. In case of new source of existing product, the material shall be directly sent to QC.
7.3 For Secondary Packaging Material only sourced Packaging Material shall be collected.
7.4 The sourced material shall be received in QC as per SOP No. IONQC009.
7.5 Handling of Sourced Raw Material
7.5.1 The Manager, Quality shall assign Quality Control Officer to test the material.
7.5.2 The Quality Control Officer shall receive the sample in “SOURCED MATERIAL QC LOG BOOK (Enclosure 10.3)” and complete all the required tests according to Standard Test Procedures (STP) and General Test Procedures (GTP).
7.5.3 All the raw data and calculations shall be entered in notebooks assigned to them.
7.5.4 The Quality Control Officer shall make entry of the results in the material specific Analytical Report Sheet.
7.5.5 The Quality Control Officer shall submit the report to Deputy of Manager, Quality. In his absence, shall submit the report to Senior Officer or Manager, Quality. He or she shall check all documents and relevant chromatogram for its correctness.
7.5.6 He or she shall forward the report to Manager, Quality for review and disposal.
7.5.7 The Manager, Quality shall check the following points before disposition of the material:
All chemical and microbiological tests comply with the requirements.
The supplier has claimed the material as injectable grade and/or pyrogen free (only in case of injectables) in their certificate of analysis.
The supplier has provided the exact result of critical test parameters (e.g. assay, solubility, LOD or water content, specific optical rotation, impurities and/or chromatographical purity, microbial contamination, bacterial endotoxins or pyrogens) in their certificate of analysis.
7.5.8 If the above points are fulfilled, then Manager, Quality and Head of Quality shall approve the material and inform Purchase Department through Form no. QC022-02.
7.5.9 In case of sourced raw material without stability data from the manufacturer, the accelerated stability study of only the active shall be done as per SOP No. IONQA026. The material must meet the requirements of the stability study.
7.5.10 If any one of the above mentioned points is not fulfilled Manager, Quality and Head of Quality shall reject the material and inform Purchase Department through Form no. QC022-02.
7.7 Handling of Sourced Packaging Material
7.7.1 The Manager, Quality shall assign Quality Control Officer to test the material.
7.7.2 The QCO shall receive the sample in “SOURCED MATERIAL QC LOG BOOK (Enclosure 10.3)” and complete all the required tests according to Standard Test Procedures (STP) and General Test Procedures (GTP).
7.7.3 All the raw data and calculations shall be entered in notebooks assigned to them along with following additional information:
Material Name & Code
Manufacturer’s Name & Lot No.
Supplier’s Name
Date of Analysis
R or P No.
QC Ref. No.
Equipment Name & ID No.
Signature of Analyst
7.7.4 The QCO shall make entry of the results in the material specific Analytical Report Sheet.
7.7.5 The QCO shall submit the report to Deputy of Manager, Quality. In his absence, shall submit the report to Senior Officer or Manager, Quality. He or she shall check all documents and relevant chromatogram for its correctness and shall sign the laboratory notebook (SOP No. IONQC002) with date.
7.7.6 He or she shall forward the report to Manager, Quality for review and disposal.
7.7.7 If all chemical and microbiological tests comply with the requirements, then machine trial shall be done with the primary packaging material. If the machine trial is successful, then Manager, Quality and Head of Quality shall approve the material and inform Purchase Department through Form no. QC022-02.
7.7.8 If the tests do not comply, Manager, Quality and Head of Quality shall reject the material and inform Purchase Department through Form no. QC022-02.
7.7.9 In case of Secondary Packaging Material the QCO shall fill report form of specific material and submit to Manager, Quality.
7.7.10 If the different physical parameters comply with the in house specifications then Manager, Quality shall approve the material and send a copy of the report form along with the supplied sample approved and initialed by him (incase of labels shade cards provided by supplier) to Purchase Department.
7.7.11 If the material fails to meet the requirements, the Manager, Quality shall inform Purchase Department of material rejection through the report form.
