Q.C Laboratory Safety SOP

1.0 OBJECTIVE:

To lay down 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 In-process 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 Q.C Department.

5.0 PROCEDURE:

5.1 To prepare a working standard of In-process/ RM follow as below.

5.2 Take any commercial batch, which is recently manufactured at the API plant, for the preparation of In-process standards and for Raw Material any material received recently at store or AR/GR grade can be considered for working standard preparation.

5.3 Take approximate 50g of sample from the latest batch and analyse 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 no.s.

5.4 Ask to process development lab in-charge to go for performance trial for next stage of the same.

5.5 If performance trail report is passing as per specification, prepare the working standard of the selected stage/RM and attach performance trail report with the working standard report.

5.6 Working standard No.s are to be allotted as below:

For In-process standards: BDIP/XXX.

For Raw material standards: BDRM/YYY.

Where, XXXand YYY stand for serial no. in three digits.

5.7 The log register is maintained for the receipt and issue of the material in 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.

5.8 Give A.R. No. same as number allotted to working standards.

5.9 If all entries are maintained in computer it should be protected and whenever the changes are made the printout should be taken and signed by Executive or Asst. Manager-QC.

5.10 In the case of solvents used as standards use AR/ GR/ HPLC grade solvents as standards.

5.11 The report of working standard should be filed in working standard file.

5.12 Prepare new W.S before the existing standard is exhausted or before two years are completed from the date of report; whichever is earlier.

5.13 Store the W.S. vials at ambient temperature or the temperature shown on the label.

5.14 Perform all the test of working standard on its expiry date as per latest test method and record the results per Annexure-II.

5.15 If the results meet the specification it can be reuse as working standard for further six months. After six months it is to be destroyed.

5.16 Destroy the expired vials of working standard after completion of shelf life and keep the record in the log register maintained as per clause5.7, stating the No. of vials destroyed, destroyed on and destroyed by.

6.0 REVISION LOG:

Revision No.	Effective Date	Reason
00	01/07/2020	New SOP

7.0 REFERENCES:

7.1 Not Applicable.

8.0 ANNEXURES:

Annexure 1: Certificate of analysis.

Annexure 2: Certificate of Reanalysis

Annexure: 1

Certificate of analysis

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. #	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: 2

Certificate of Reanalysis

QUALITY CONTROL DEPARTMENT CERTIFICATE OF REANALYSIS
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. #	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: