SOP for Receipt and Maintenance of Working Standards of API

1.0 OBJECTIVE

To lay down the procedure for receipt and maintenance of working standards of API.

2.0 SCOPE

This procedure is applicable for receipt and maintenance of working standard of Inprocess Stages and Raw Materials received at API plant.

3.0 RESPONSIBILITY

3.1 Doing: Technical Assistant/Executive
3.2 Checking: Executive / Manager

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

5.1 To prepare a working standard of Inprocess/RM follow as below.
5.2 Take any commercial batch, which is recently manufactured at the API plant, for the preparation of Inprocess Standards and for Raw Material any material received recently at the store or AR/GR grade can be considered for working standard preparation.
5.3 Take approximate 50gms of the sample from the latest batch and analyze twice as per available specification and method and compare with reference std. available. The difference between two assay results should not be more than 0.5 %. Average of the results are recorded as per Annexure – I.
Prepare vials accordingly and affix the labels indicating Product Name, Stage No, Working Standard No., Effective Date, Use Before, and Potency of the material and Vial nos.
5.4 Ask to process development lab incharge to go for performance trial for next stage of the same.
5.5 If performance trial report is passing as per specification, prepare the working standard of the selected stage/RM and attach performance trial report with the working standard report.
5.10 Working Standard Nos. are to be allotted as below :
For Inprocess Standards: BDIP/XXX
For Raw Material Standards: BDRM/YYY
Where XXX AND YYY stand for serial no. in three digits.
5.11 The log register is maintained for the receipt and issue of the material in the computer or a hard copy maintaining Product name, Stage/Batch/Lot/ A.R. No., Date of Receipt, Date of Analysis, Received Quantity, No. of vials prepared, No. of Vials issued, Issued Date etc.
5.12 Give A.R. No. same as number allotted to Working Standards.
5.13 If all entries are maintained in the computer it should be protected and whenever the changes are made the printout should be taken and signed by Executive or Asst. manager - QC.
5.14 In the case of solvents used as standards use AR/GR/HPLC grade solvents as standards.
5.15 The report of working standard should be filed in working standard file.
5.16 Prepare new W.S. before the existing standard is exhausted or before two years are completed from the date of the report; whichever is earlier.
5.17 Store the W.S. vials at ambient temperature or the temperature shown on the label.
5.18 Perform all test of working standard on its expiry date as per latest test method and record the results per Annexure – II.
5.19 If the results meet the specification it can be reused as working standard for further six months. After six months it is to be destroyed.
5.20 Destroy the expired vials of working standard after completion of shelf life and keep the record in the log register maintained as per clause 5.11, stating the No. of vials destroyed, Destroyed on and destroyed by.

Related: SOP for Procurement and Handling of Reference Standard

6.0 ABBREVIATIONS

A.R. No. = Analytical Report Number
W.S. = Working Standard
API = Active Pharmaceuticals Ingredient
AR = Analytical Reagent
GR = Guaranteed Reagent
QC = Quality Control

Annexure – I

QUALITY  CONTROL  DEPARTMENT CERTIFICATE OF ANALYSIS
Name of Product			:				W.S. No.			:
Date of Testing			:				Batch No.			:
Effective Date			:				Qty. in gms			:
Use Before			:				A.R. No.			:
Ref. Std. No.			:				No. of Vials			:
Analysed as per			:
Sr.No.	TESTS				LIMITS				RESULTS
Test protocol as per specification
Remarks   :  Complies / does not comply as per above specifications
Prepared  By Date		: :		Checked By Date		: :		Approved By Date			: :

Annexure – II

QUALITY  CONTROL  DEPARTMENT CERTIFICATE OF REANALYSIS
Name of Product			:				W.S. No.			:
Retest Date			:				Batch No.			:
Effective Date			:				Qty. in gms			:
Use Before			:				A.R. No.			:
Ref. Std. No.			:				Vial No.			:
Analysed as per			:
Sr.No.	TESTS				LIMITS				RESULTS
Test protocol as per specification
Remarks   :  Complies / does not comply as per above specifications
Prepared  By Date		: :		Checked By Date		: :		Approved By Date			: :

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