SOP For Management of Reference Standard and Reference Solution

1. OBJECTIVE:

The purpose of this SOP is to lay down a procedure Management of Received, handling, storage and usage of reference standard and reference solution.

2. SCOPE: 

This SOP is applicable to reference standard and reference solution used at quality control department.

3. RESPONSIBILITY:
   • Analyst or his designee shall be responsible for follow the SOP.
     1. The Head of Quality Control Department or his designee shall be responsible and implementation of the SOP.

4. PROCEDURE:

 4.1         Reference standards: 

4.1.1 4.1.2	At the time of Receipt of the Reference substances, check current lot, material safety data sheet and certificate (If available) and Store all Reference standards / impurity standards as per the storage condition mentioned in respective MSDS from supplier. Reference substances or Reference standards are authentic purified chemicals or substances supplied by the official pharmacopoeial commissions or any authentic supplier or manufacturer.
4.1.3 4.1.4	In case reference standard is not available in any of the pharmacopoeial catalog, manufacturer shall be requested for their reference standards / working standards with certificate of analysis. Inventory and consumption of Reference standards shall be maintained as per Annexure I, and Maintain an index of all reference substances/standards as per annexure II.
4.1.5 4.1.6 4.1.7 4.1.8 4.1.9 4.1.10	Store all the reference substances at temperature between 2 to 8°C or as per supplier recommended storage condition. Allow it to attain ambient temperature before use.  Check the validity of lot No. / Batch No. of reference substances/ standard from official catalogue of pharmacopoeial bodies at every three months. Reference standard shall be verified as per Annexure VII. Verification of Reference standard shall be done with following websites BPCRS http://www.pharmacopoeia.gov.uk EPCRS http://crs.edqm.eu USPRS http://www.usp.org In case the Reference standard are found to be consumed /expired during verification, the indent for procurement of fresh lot shall be initiated by Manager QC Reference substance should be up to the lot / Batch No. is valid.
4.1.11 4.1.12 4.1.13 4.1.14 4.1.11 4.1.12 4.1.13 4.2 4.2.1 4.2.2 4.2.3 4.2.4 4.2.5 4.2.6 4.2.7 4.2.8 4.2.9 4.2.10 5.0	Whenever a new lot is received, replace old lots / batches of reference substances with the new lots.  Assume the potency to be 100% if the same is not specified on the original reference substance container or catalogue of respective pharmacopoeial bodies. Where drying of reference substance is specified, dry only the minimum required quantity of the reference substance. Do not dry the original container under any circumstances.  Do not transfer the dried/ weighed substance back to the container. Make relevant entries in the usage log every time of the reference standard is used. Destroy the old reference standard and mention the details of destruction in usage log book. Use Minimum quantity of reference standard / impurity standard used for preparation of solution as wherever required.  Reference substance solutions : Prepare the RS solution only whenever it is required. Allot a reference number to it as illustrated below:   RSSoln/A01/01. Where as  ‘RS Soln’ stands for Reference Substance Solution,   ‘A01’ stands for the unique number for a particular solution in the alphabetical series and   ‘01’ stands for the version number of reference solution. Maintain the Record of reference solution Like Name of Reference standard / Impurity standard , Reference solution No., Required for Test, Preparation of solution etc as per Annexure – V. After initial analysis, maintain the records of data related to the solution used e.g. copy of HPLC/GC chromatograms attached with the reference solution preparation and usage log. (Annexure – VI). Prepare an Index of reference solution as per annexure IV. After every analysis, compare the data obtained related to RS solutions used with the data of initial analysis.  If any significant change is observed discard the solution and prepare the fresh solution. Record the observation. Store reference substance solutions in tightly closed bottles with proper labeling as per Annexure III and protect them from light Store all the reference solutions at a temperature between 2 to 8°C. Allow it to attain ambient temperature before use.  Before use, Check the solution for colour, clarity and foreign particles. If change is observed, discard the RS solution. Prepare fresh solution, Retain the same solution number but revise version number. E.g. RSSoln/A01/02 and so on. If the Lot No. / B.No. Of the reference substance used for the preparation of reference solution) is changed; use the reference solution till new lot is received. TRAINING:  Trainer                         : Head – Quality Control   Trainees             : Quality Control chemist / Sectional Head.

6. DISTRIBUTION:

Controlled Copy No.1:  Head of Department – Quality Assurance

Controlled Copy No. 2:  Head of Department – Quality Control

Original Copy :  Head – Quality Assurance

7. ANNEXURE: Annexure I     :  Reference Standard Usage Log Book

Annexure II   :   List of Reference standard.

Annexure III  :  Reference solution Label

Annexure IV   :  Reference solution index

Annexure V    : Reference solution Preparation 

Annexure VI    : Reference solution usage log

Annexure VII   : Verification of Reference standard.

8. REFERENCES (S):

Nil

9. REVISION HISTORY: