SOP FOR PREPARATION OF STANDARD TESTING PROCEDURE FOR RAW MATERIALS, BULK, INTERMEDIATE AND FINISHED PRODUCT

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1.0   OBJECTIVE

To lay down a standard procedure for the preparation of Standard Testing Procedure for Raw Material,

Bulk product, Intermediate product, finished product.

2.0   SCOPE

This SOP is applicable for the preparation of Standard Testing Procedure for Raw Material, Bulk

product, Intermediate product, finished product in Quality Control Laboratory

3.0   RESPONSIBILITY

Officers/ Executive – Quality Control shall be responsible for follow the procedure mentioned in this

SOP.

4.0   ACCOUNTABILITTY

Head QC and Head QA shall be accountable for compliance of this SOP.

5.0   ATTACHMENTS

Standard testing procedure for Raw Materials                                                         Attachment-I

Standard testing procedure for Bulk Products                                                         Attachment-II

Standard testing procedure for Intermediate Products (Uncoated)                   Attachment-III

Standard testing procedure for Intermediate Products                                       Attachment-IV

(Coated, Filled Capsules, Sachet, Syrup)

Standard testing procedure for Finished Products                                               Attachment-V

6.0   PROCEDURE

6.1   Quality Control Department shall prepare the STP for Raw Material, Bulk product, Intermediate

Product (uncoated), Intermediate Product (Coated, Filled Capsules, Sachet, Syrup), Finished product as

Per Attachment-I, II, III, IV and V.

  •  The STP shall be prepared by using reference pharmacopoeia or other Reference source.

6.3   Each STP shall have a unique number that is given below:-

STP/RM/000 (For Raw material)

STP/BL/T/000 (For Bulk Product)

STP/IM/T/000 (For Intermediate Product of Uncoated Tablets)

STP/SF/T/000 (For Intermediate Product of Coated Tablets, Capsules, Sachet, Liquid)

STP/FP/T/000 (For Finished Product)

Ex.- STP/FP/T/000, where STP/ for Standard testing procedure,  FP/ for Finished products, T/ for

Tablets and the 000 for serial number. In case of Syrup, Sachet and Capsules T/ will be replace by C/

for Capsules, ST/ for Sachet and S/ for Syrup.

6.4   Once a number is allocated to any STP the same number shall not be repeated to any other STP.

6.5   All the STP shall be approved and controlled by Quality Assurance Department.

6.6   All the STP shall be revised whenever there is any change in pharmacopoeia or relevant Sources.

6.7   Any change in STP shall be done through change control procedure.

7.0   REFEENCES

In-house

8.0   ABBREVIATIONS

SOP: Standard Operating Procedure

QC: Quality Control

QA: Quality Assurance

STP: Standard Testing Procedure

9.0   DISTRIBUTION LIST

Quality Assurance

Quality Control

10.0  HISTORY OF REVISION

Version No. Effective Date Reason for Revision
    Attachment-I
  •  Description:

 

  • Solubility:

 

  • Identification:

 

  • Specific Optical Rotation: (If applicable)

 

  • Related Substances: (If applicable)

 

  • Melting Point: (If applicable)

 

  • Appearance of Solution: (If applicable)

 

  • Heavy Metals: (If applicable)

 

  • Chloride: (If applicable)

 

10.0 Light Absorption: (If applicable)

 

  • Arsenic: (If applicable)

 

12.0 Sulphate: (If applicable)

 

  • Readily Carbonisable Substances: (If applicable)

 

  • Sulphated Ash/Loss on ignition/Residue on ignition/Ash:

 

  • Water: (If applicable)

 

  • Loss on drying: (If applicable)

 

  • Other Tests: (If applicable)

     

18.0 Assay:

Attachment-II

Description :

  • Assay :

          (Limit:                                    )

 

Results

     

Attachment-III

  • Description :
  • Average weight :
  • Uniformity of weight :
  • Hardness :
  • Disintegration Time :
  • Dimensions of Tablets :
  • Assay :

          (Limit:                                 )

Result

 

Attachment-IV

For Coated Tablets

  • Description :
  • Average weight :
  • Uniformity of weight :
  • Hardness :
  • Disintegration Time :
  • Dimensions of Tablets :
  • Dissolution :
  • Assay :

 

               For Capsules

  •  Description :
  •  Average weight :
  •  Uniformity of weight :
  •  Hardness :
  •  Disintegration Time :
  •  Dimensions of Tablets :
  •  Dissolution :
  • Assay :

 

FOR SYRUP

  • Description :
  • Net Volume :
  • pH :
  • Assay :

 

FOR SACHET

  • Description :
  • Net weight:
  • Assay :
  • Attachment-V
  • Description :
  • Average weight :
  • Uniformity of weight :
  • Identification Test :
  • Hardness :
  • Disintegration Time :
  • Dimensions of Tablets :
  • Dissolution :
  • Leak Test :

10.0)        Related substances :

11.0)        Assay :

12.0)        Microbiological Purity :

                 Abbreviations

             

 

  

SOPs