1.0 Purpose
1.1 To establish a formulation and manufacturing process to develop and validate method of analysis in order to achieve a satisfactory quality product.
2.0 Scope
2.1 This Sop is applicable for all new formulation development projects at "NAME" Pharmaceuticals Ltd.
3.0 Responsibility
3.1 Operator, PD/ Officer, PD/ Sr. Officer, PD is responsible for carrying out the procedure.
4.0 Abbreviations and Definitions
4.1 SOP= Standard Operating Procedure
4.2 QA= Quality Assurance
4.3 PD= Product Development
4.4 QC= Quality Control
4.5 COA= Certificate of Analysis
4.6 INN= International Non-proprietary Name
4.7 WHO= World Health Organization
4.8 BMR= Batch Manufacturing Record
4.9 Lab Batch: Lab batch means a specific quantity of a drug or other material that is intended to have uniform character and quantity, within specified limits and is produced according to a single manufacturing order during the same cycle of manufacture.
5.0 Materials and Equipment
5.1 Not Appreciable
6.0 Precaution / Health and Safety Considerations
6.1 Wear dust mask, safety goggles, dress and hand gloves during handling of raw materials.
6.2 Ensure that all raw materials are within the shelf life.
7.0 Procedure
7.1 Prepare working formulation and lab batch BMR and Checked from Sr. Executive, PD/ Asst. Manager, PD and also approved from Manager / Head of QA.
7.2 Prepare product specification and taken checked from Asst. Manager, PD and also taken approval from Head of QA.
7.3 Raise a requisition to Store (if necessary) for required quantity of Raw materials.
7.4 Dispense the raw materials & record the weight and reference number in the batch manufacturing record of lab trail.
7.5 Manufacture the lab batch according to the procedures of BMR and note the observations.
7.6 Perform physical and chemical tests of lab batch to ensure that it comply with the specification.
7.7 Repeat operation with any change/ modification of process and/or formulation until a satisfactory final product is obtained.
7.8 Send samples to Marketing Department (if satisfactory) for approval.
7.9 Develop effective Method of Analysis for testing of Lab Batch product.
7.10 Complete the Method Validation.
7.11 In-case of INN product send the samples with COA, MOA, Analytical Method Validation Report, Working Standard, Working Standard Certificate and declaration letter to Drugs Administration.
7.12 Keep the sample for stability study in designated packaging modes.
7.13 Dispose of the remaining waste of Lab batch product as per respective SOP.
8.0 Reference Document
8.1 WHO Guidelines, volume 2, second edition.
9.0 Annexure
9.1 Not Appreciable
10.0 Revision History
Revision No. | Brief reason for the revision | Effective Date | Remarks |
01 | New |
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02 |
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11.0 Training
11.1 Head of Product Development or his/her nominee shall give the SOP training before effective date.
