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1.0 OBJECTIVE:
This procedure describes the procedure for preparation and approval of Analytical Specifications,
Standard Test Procedures and Worksheets.
2.0 SCOPE:
This procedure is applicable to preparation and approval of Analytical Specification, Standard Test
Procedure (STP) and Worksheet of Raw materials, Bulk, Packaging Materials and General Items.
.

3.0 RESPONSIBILITY:
Preparation & Follow-ups : Quality Control Chemists / Officers / Executives / Sr. Executives
Checking & Implementation : Head of the department (HOD) / Designee
Approvals : Head Quality Assurance
Authorization : Plant Head

4.0 ACCOUNTABILITY:
Head Quality Control and Quality Assurance.

5.0 ABBREVIATIONS:
SOP : Standard Operating Procedure
No. : Number
CCF : Change Control format
HH : Higgs healthcare
QC : Quality Control
QA : Quality Assurance
IPA : Isopropyl Alcohol

6.0 PRECAUTIONS:
6.1 Use dedicated slippers only provided in the change room for going into the Quality Control
laboratory.
6.2 Disposal dress is only allowed for visitor / other department personnel at time of visit in
laboratory.

7.0 MATERIALS AND EQUIPMENTS REQUIRED:

7.1 MATERIALS: Apron, cap, slipper and 70% IPA, shoe cover, disposal dress.
7.2 EQUIPMENTS: N.A.

8.0 PROCEDURE :

8.1 Prepare the Analytical Specifications, STP and Worksheet to assess the quality of the product by
including all such tests and parameters which are necessary to control its quality and render it
suitable for its end use
8.2 The specification, STP and Worksheet are prepared for all raw materials, packaging material, In-
process Testing samples such as blend, uncoated tablets, coated tablets, filled capsules, finished

--- PREPARED BY CHECKED BY APPROVED BY AUTHORISED BY

Designation Officer-QC/Designee HOD –QC-Designee HOD –QA/Designee Plant Head
Sign.
Date
Name
FORMAT NO. : HH-III/QA/001/F-01/00
COMPANY CONFIDENTIAL
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product and general items which should be tested before use for manufacturing and packing/
dispatch of product as per respective format (Refer point No. 7.0, Annexure).
8.3 Specification and STP of Pharmacopoeial Raw Material and Finished Product are prepared by
referring pharmacopoeia.
8.4 In-house specification and STP are made by using the specification received from approved
Vendor or by developing in-house procedure.
8.5 After receiving the production plan, Quality Control Department identifies the new specification for
preparation.
8.6 The specification, STP and Worksheet are prepared/ revised by QC Chemist/ Officer as per
requirement, checked by QC Officer/ Executive and approved by QC Head or his/ her designee.
8.7 Type of Analytical Specification/ STP/ Worksheet
8.7.1 Raw Material Specification/ STP/ Worksheet
8.7.2 Finished Product Specification/ STP/ Worksheet
8.7.3 In-process Testing Specification/ STP/ Worksheet
8.7.4 Packaging Material Specification/ STP/ Worksheet
8.7.5 General item Specification/ STP/ Worksheet
8.8 Specification, STP and Worksheet contents
8.9 Header of the Specification, STP and Worksheet contents
8.9.1 Company logo with name and address
8.9.2 Name of Department (Quality Control Department)
8.9.3 Topic (Type of Specification, STP and Worksheet)
8.9.4 Name of the Material/ Product
8.9.5 Specification Number/ STP Number/ Worksheet Number
8.9.6 Review date
8.9.7 Page Number
8.9.8 Footer of the Specification, STP and Worksheet contents
8.9.9 A table contains Prepared by, Checked by and Approved by for signing with date,
name and designation.
8.9.10 Attachment No. as mentioned in SOP.
8.9.11 The following general informations related with raw material are incorporated in first
page of Raw Material

8.10 The following general informations related with raw material are incorporated in first page of Raw
Material Specification.
8.10.1 Name of the material
8.10.2 Category
8.10.3 Chemical Name (INN Name) International Nonproprietary Name
8.10.4 CAS No.
8.10.5 Molecular formula
8.10.6 Molecular weight
8.10.7 Structural formula
8.10.8 Pharmacopieal reference
8.10.9 Sampling procedure
8.10.10 Quantity of sample to be taken
8.10.11 Retest period
8.10.12 Test to be carried out in retesting

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Sign.
Date
Name
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8.10.13 Storage condition

8.11 The following general informations related with finished product are incorporated in first page of
Finished Product Specification.
8.11.1 Pharmaceutical dosage form
8.11.2 Composition
8.11.3 Category
8.11.4 Pharmacopieal reference
8.11.5 Quantity of sample to be taken
8.11.6 Storage condition

8.12 The following general informations related with In-process Testing samples are incorporated in
first page of In-process testing specification.
8.12.1 Reference
8.12.2 Composition
8.12.3 Quantity of sample to be taken
8.13 The following general informations related with general item are incorporated in first page of
general item Specification.
8.13.1 Name of the material
8.13.2 Category
8.13.3 Chemical Name (INN Name) International Nonproprietary Name, if available
8.13.4 Molecular formula
8.13.5 Molecular weight
8.13.6 Structural formula
8.13.7 Quantity of sample to be taken
8.13.8 Storage condition
8.14 The following general informations related with raw material are incorporated in first page of Raw
Material Analytical Worksheet.
8.14.1 Issued by
8.14.2 Material Name
8.14.3 Batch number
8.14.4 Quantity Received
8.14.5 Manufacturing Date
8.14.6 Expiry Date
8.14.7 Manufactured by
8.14.8 Supplied by
8.14.9 GRN number
8.14.10 Date of Received
8.14.11 A.R. number
8.14.12 Date of analysis completion
8.14.13 Specification number
8.14.14 Standard Test Procedure number
8.15 The following general informations related with finished product are incorporated in first page of
Finished Product Analytical Worksheet.
8.15.1 Issued by
8.15.2 Product Name
8.15.3 Batch number
8.15.4 Batch Size
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Name
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8.15.5 Manufacturing Date

8.15.6 Expiry Date
8.15.7 A.R. number
8.15.8 Date of analysis completion
8.15.9 Specification number
8.15.10 Standard Test Procedure number
8.16 The following general informations related with In-process Testing samples are incorporated in
first page of In-process testing Analytical Worksheet.
8.16.1 Issued by
8.16.2 Product Name
8.16.3 Batch number
8.16.4 Batch Size
8.16.5 Manufacturing Date
8.16.6 Expiry Date
8.16.7 A.R. number
8.16.8 Date of analysis completion
8.16.9 Specification number
8.16.10 Standard Test Procedure number
8.17 The following general informations related with packaging material are incorporated in first page
of Packaging Material Analytical Worksheet
8.17.1 Issued by
8.17.2 Material Name
8.17.3 Batch number/ Lot Number
8.17.4 Quantity Received
8.17.5 GRN number
8.17.6 Date of Received
8.17.7 A.R. number
8.17.8 Date of analysis completion
8.17.9 Specification number
8.17.10 Standard Test Procedure number
8.18 The following general informations related with General Items are incorporated in first page of
General Item Analytical Worksheet
8.18.1 Issued by
8.18.2 Material Name
8.18.3 Batch number
8.18.4 Quantity Received
8.18.5 Manufacturing Date
8.18.6 Expiry Date
8.18.7 Manufactured by
8.18.8 Supplied by
8.18.9 Intimation number
8.18.10 Date of Received
8.18.11 A.R. number
8.18.12 Date of analysis completion
8.18.13 Specification number
8.18.14 Standard Test Procedure number
Mute

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8.19 The test to be performed for stability study is highlighted by keeping ‘*’ at the ending of the test
name.
8.20 Finished Product Specification contains Shelf Life Specification (as per Pharmacopieal limit) .
8.21 All pages of Specification, STP and Worksheet are signed and authenticated by QC Chemist/
Officer as Prepared by, QC Senior Officer/ Executive as Checked by and QC Head or his/ her
designee as Approved by.
8.22 Specification is reviewed by authorized person at prescribed frequency or earlier as required and
identified for revision, if any.
8.23 Each new revision shall take into account the latest data, current technology used, regulatory
and Pharmacopoeial requirement.
8.24 All pages of the specification, STP and Worksheet have respective page number of total page
numbers e.g. If there are three pages in specification, the first page shall bear page 1 of 3,
second page 2 of 3 and so on.
8.25 The numbering system for Analytical Specification, STP and Worksheet is as follows;

8.25.1 Numbering system for Standard Test Specification, Standard Test Procedure,
Analytical work sheet & General Test Procedure.
8.25.1.1 Document numbering system for Standard Test Specification is as below:
AA/STS/XXX,
Where AA: Represent the category
RM : Raw material,
FP : Finished Product,
PM : Packing Material,
BI : Bulk Sample
MI: Miscellaneous Item
All the category series is started from 001.
STS: Standard Test Specification
XXX: Serial Number started from 001 for different category.

For example: First STS prepared for raw material is RM/STS/001

First STS prepared for Packing material is PM/STS/001
First STS prepared for Finished product is FP/STS/001
First STS prepared Bulk sample is BI/STS/001
First AWR prepared Miscellaneous Item is BI/AWR/001

8.25.1.2 Document numbering system for Standard Test Specification is as below:

AA/AWR/XXX,
Where AA: Represent the category
RM : Raw material,
FP : Finished Product,
PM : Packing Material,
BI : Bulk Sample

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MI: Miscellaneous Item

All the category series is started from 001.

AWR: Analytical work sheet
XXX: Serial Number started from 001 for different category.

For example: First AWR prepared for raw material is RM/AWR/001

First AWR prepared for Packing material is PM/AWR/001
First AWR prepared for Finished product is FP/AWR/001
First AWR prepared Bulk sample is BI/AWR/001
First AWR prepared Miscellaneous Item is BI/AWR/001

8.25.1.3 Document numbering system for Standard Test Specification is as below:

AA/STS/XXX,
Where AA: Represent the category
RM : Raw material,
FP : Finished Product,
PM : Packing Material,
BI : Bulk Sample
MI: miscellaneous Item
All the category series is started from 001.
STS: Standard Test Specification
XXX: Serial Number started from 001 for different category.

For example: First STS prepared for raw material is RM/STS/001

First STS prepared for Packing material is PM/STS/001
First STS prepared for Finished product is FP/STS/001
First STS prepared Bulk sample is BI/STS/001
First STS prepared Miscellaneous Item is BI/AWR/001

8.1.8.2 Document numbering system for General Test Procedure is as below :

GTP – XXX
where GTP - General test Procedure
XXX - Serial Number started from 001
For example: First numbering of any GTP is GTP-001

8.26 All numbering system will be applicable to the documents which will revise after effective of
SOP.
8.27 Completion of specification is indicated by “***End of document***”.

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FORMAT NO. : HH-III/QA/001/F-01/00
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8.28 Approval & Authorization of Standard test Specification / Standard test Procedure / General test
Specification / General test Procedure:
8.28.1 Standard test Specification/Standard test Procedure/General test Specification/
General test and Analytical worksheet Procedure are prepared by QC officer,
Checked by QC Head and approved by QA Head.
8.29 Issuance & control of Standard test Specification /Standard test Procedure/General test
Specification/ General test Procedure:
8.29.1 Approved STS/STP/GTP\AWR are issued from QA department stamp with
controlled copy and issued by QA person.
8.29.2 Retrieval of distributed copy after revision of document.
8.29.3 Distribution of STS/STP/GTP received from external customers or as master copy by
Quality assurance department. A controlled copy is issued to QC department
distributed as per the QA SOP.
8.30 Master copy of obsolete version of STS/STP/GTP\AWR are stamped as ‘OBSOLETE COPY’
for reference only and retained in archives for 5 years by QA Department
8.30.1 Controlled copies of the obsolete STS/STP/GTP are destroyed immediately after
8.30.2 implementation of new revised version.
8.30.3 For distribution of STS/STP/GTP Annexure - V should be followed.
8.31 Revision of Standard test Specification /Standard test Procedure/ General test Specification/
/ General Test Procedure shall be done if any:
8.31.1 Change in Pharmacopoeia for specification and/or method.
8.31.2 Regulatory or Statutory requirement.
8.31.3 Frequency for revision of STS/STP/GTP is two year ± 1month from the effective date
or when need arises whichever comes earlier.
8.31.4 If there is no any change required in the document at the time of periodic revision of
8.31.5 Document then QA will forward Master STS/STP/GTP for further two year by put
“REVIEWED with No Change Made” stamp in blue ink at center of the on Master
STS/STP/GTP & again issued controlled copy to quality control department. This
procedure will be followed only once not applicable for next time revision.
REVIEWED

(No change made)

Review Date

Next Due Date

Sign. Date

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8.4.5 STS/STP/GTP is updated & History sheet is maintained for the Changes.
8.5 Destruction of Obsolete copy of Standard test Specification /Standard test Procedure/
General Test Specification/ General Test Procedure shall be done after 5 Years.

9.0 ENCLOSURES:
Annexure-I List of Specification (HH-III\QC\008\F-01\00)
Annexure-II List of Standard Test procedure (HH-III\QC\008\F-02\00)
List of Analytical Work Sheet
Annexure-III Raw material specification HH-III\QC\008\F-03\00)
Annexure-IV Raw material Standard test Procedure (HH-III\QC\008\F-04\00)
Annexure-V Raw material Analytical work Sheet (HH-III\QC\008\F-05\00)
Annexure-VI Finished Product specification HH-III\QC\008\F-06\00)
Annexure-VII Finished Product Standard test Procedure (HH-III\QC\008\F-07\00)
Annexure-VIII Finished Product Analytical worksheet (HH-III\QC\008\F-08\00)
Annexure-IX In process Sample specification (HH-III\QC\008\F-09\00)
Annexure-X In process Standard test Procedure (HH-III\QC\008\F-10\00)
Annexure-XI In process Analytical worksheet (HH-III\QC\008\F-11\00)
Annexure-XII Packaging Material Sample Specification (HH-III\QC\008\F-12\00)
Annexure-XIII Packaging Material Standard test procedure (HH-III\QC\008\F-13\00)
Annexure-XIV Packaging Material Standard test procedure (HH-III\QC\008\F-14\00)
Annexure-XV Miscellaneous Item Specification (HH-III\QC\008\F-15\00)
Annexure-XVI Miscellaneous Item Standard test procedure (HH-III\QC\008\F-16\00)
Annexure-XVII Miscellaneous Item Analytical worksheet (HH-III\QC\008\F-17\00
Annexure-XVIII General test procedure (HH-III\QC\008\F-18\00)
Annexure-XVIII General test procedure (HH-III\QC\008\F-19\00)
Annexure no. XVIX - STP/STS/GTP Issuance and retrieval Register (HH-III\QC\008\F-19\00)
Annexure no. XX - AWR Issuance and retrieval Register (HH-III\QC\008\F-20\00)

10.0 DISTRIBUTION:
10.1 The SOP shall be distributed to respective department by QA. The QA department shall
Authorize for the distribution of SOP and shall sign for “Issued by“
Follow the distribution of SOP as per following:
Master Copy - QA Department (In documentation cell)
Control Copy - User Department
10.2 The Revised SOP shall be distributed only after recall of superseded SOP.

11.0 REFERENCE

11.1 Range Guideline MHRA – Rules and Guidance for Pharmaceutical Manufacturers and
Distributors – 2017, Section-2, Part-I (DOCUMENTATION)
11.2 Schedule L1, Drugs & Cosmetics (Third Amendment) Rules, 2008

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12.0 HISTORY OF REVIEW:

PREVIOUS PREVIOUS CCF NO. (If any) REASON FOR REVIEW
EFFECTIVE DATE REVISION NO.
Nil Nil Nil New SOP

END OF THE SOP

ANNEXURE-I

LIST OF SPECIFICATION

LIST OF ___________________SPECIFICATION

Sr.No. Material Specification Number Effective Date Review Date

Format No:.HH-III\QC\008\F-01\00

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Annexure-II
LIST OF STANDARD TEST PROCEDURE

LIST OF ___________________STANDARD TEST PROCEDURE

Sr.No. Material Specification Number Effective Date Review Date

Format No:.HH-III\QC\008\F-02\00

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ANNEXURE NO-III
RAW MATERIAL SPECIFICATION

RAW MATERIAL SPECIFICATION

Specification
Effective Date
Number Name of Raw Material
Revison Number Review Before
Item Code Page
01 of -----

Name of the material

Category

Chemical Name (INN Name) International

Nonproprietary Name

CAS No
Molecular formula

Molecular weight

Pharmacopieal reference

Pharmacopieal reference

Retest period

Test to be carried out in retesting

Storage

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Designation
Name
Sign. & Date

Format No:.HH-III\QC\008\F-03\00

COMPANY CONFIDENTIAL
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RAW MATERIAL SPECIFICATION

Specification
Effective Date
Number Name of Raw Material
Revison Number Review Before
Item Code Page
02 of -----

S.No TEST

HISTORY OF REVIEW
Date Previous Revision No. CCF No. if any Reason for Review

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ANNEXURE NO-IV
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RAW MATERIAL STANDARD TEST PROCEDURE

RAW MATERIAL STANDARD TEST PROCEDURE

STP NO. Effective Date
Review Before
Revison Number Name of Raw Material
Page 02 of -----
Item Code
1. Description

2. Solubility
3. Identification
4. Testing Parameter

HISTORY OF REVIEW
Date Previous Revision No. CCF No. if any Reason for Review

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ANNEXURE NO-VI
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Raw Material Analytical Worksheet

IUSSED BY
Material Name:
Batch NO. Quantity Recived:
MFG Date: EXP. Date:
Mfged by: Supplied by:
GRN No.: Recived Date:
A.R.No: Date of Anlaysis completed:
Specification No.:. Standard test procedure:

1.0 Description

Specification

Observation_____________________________________________________________________________

____________________________________________________________________________________

Analysed by___________________ Checked by________________________

2.0 Solubility

Specification

Observation_____________________________________________________________________________

____________________________________________________________________________________

Complies/ does not comply

Analysed by___________________ Checked by________________________

3.0 Identification

Specification

Observation_____________________________________________________________________________

____________________________________________________________________________________

Complies/ does not comply

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Analysed by___________________ Checked by________________________

4.0Test parameter
Instrument ID NO. _________________ Calibration Due to_________________

Balance ID NO. __________________ Calibration Due to_________________

Solution Preparation Record

Sr.NO WS/RS/Reagent/Solvent WS No./Batch NO./LOT No Validity

Sr.NO Laboratory Solution Preparation NO. Validity

Procedure:

Acceptance Criteria:

Complies/ does not comply

Analysed by___________________ Checked by________________________

Format No:.HH-III\QC\008\F-05\00

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ANNEXURE NO-VI
FINISHED PRODUCTSPECIFICATION

FINISHED PRODUCTSPECIFICATION

Specification FINISHED PRODUCT

Effective Date
Number NAME
Review Before
Revison Number
Page
01 of -----

Composition

Pharmacopeial Reference

No. of sample Quantity to be taken Quantity of sample for Analysis

Quantity of sample for Control

Storage

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FINISHED PRODUCT SPECIFICATION

Specification Name of Raw Material Effective Date

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Number
Review Before
Revison Number
Page
02 of -----

S.No TEST

HISTORY OF REVIEW
Date Previous Revision No. CCF No. if any Reason for Review

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ANNEXURE NO-VII
FINISHED PRODUCT STANDARD TEST PROCEDURE

FINISHED PRODUCT STANDARD TEST PROCEDURE

STP NO. Effective Date
Review Before
Name of Raw Material
Revison Number
Page
02 of -----
1. Description
2. Identification

HISTORY OF REVIEW
Date Previous Revision No. CCF No. if any Reason for Review

--- PREPARED BY CHECKED BY APPROVED BY AUTHORISED BY

Designation
Name

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Sign. & Date

Format No. HH-III\QC\008\F-06\00

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ANNEXURE NO-VIII
FINISHED PRODUCT ANALYTICAL WORKSHEET

FINISHED PRODUCT ANALYTICAL WORK SHEET

STP NO. Effective Date
Review Before
NAME OF FINISHED PRODUCT
Revison Number
Page
02 of -----

IUSSED BY
Product Name:
Batch No. Batch Size
MFG Date: EXP. Date:
A.R.No: Date of Anlaysis completed:
Specification No.:. Standard test procedure:

1.0 Description

Specification

Observation_____________________________________________________________________________

____________________________________________________________________________________

Analysed by___________________ Checked by________________________

3.0 Identification

Specification

Observation_____________________________________________________________________________

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____________________________________________________________________________________

Complies/ does not comply

Analysed by___________________ Checked by________________________

3.0Test parameter
Instrument ID NO. _________________ Calibration Due to_________________

Balance ID NO. __________________ Calibration Due to_________________

Solution Preparation Record

Sr.NO WS/RS/Reagent/Solvent WS No./Batch NO./LOT No Validity

Sr.NO Laboratory Solution Preparation NO. Validity

Procedure:

Acceptance Criteria:

Complies/ does not comply

Analysed by___________________ Checked by________________________

Format No.HH-III\QC\008\F-08\00

--- PREPARED BY CHECKED BY APPROVED BY AUTHORISED BY

Designation Officer-QC/Designee HOD –QC-Designee HOD –QA/Designee Plant Head
Sign.
Date
Name
FORMAT NO. : HH-III/QA/001/F-01/00
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ANNEXURE NO-IX
INPROCESS SAMPLE SPECIFICATION

INPROCESS SAMPLE SPECIFICATION

Specification
Effective Date
Number
NAME OF INPROCESS
Review Before
SAMPLE
Revison Number
Page
01 of -----

Composition

Pharmacopeial Reference

No. of sample Quantity to be taken

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Designation
Name
Sign. & Date
COMPANY CONFIDENTIAL
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INPROCEES SAMPLE SPECIFICATION

Specification
NAME OF INPROCESS Effective Date
Number
SAMPLE
Revison Number Review Before

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Designation Officer-QC/Designee HOD –QC-Designee HOD –QA/Designee Plant Head
Sign.
Date
Name
FORMAT NO. : HH-III/QA/001/F-01/00
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Page
02 of -----

S.No TEST

HISTORY OF REVIEW
Date Previous Revision No. CCF No. if any Reason for Review

--- PREPARED BY CHECKED BY APPROVED BY AUTHORISED BY

Designation
Name
Sign. & Date
Format No.:HH-III\QC\008\F-09\00

COMPANY CONFIDENTIAL
Uncontrolled copy if QA stamp is not red
ANNEXURE NO-X
INPROCESS SAMPLE STANDARD TEST PROCEDURE

INPROCESS SAMPLE STANDARD TEST PROCEDURE

STP NO. Effective Date
NAME OF INPROCESS Review Before
Revison Number SAMPLE
Page 02 of -----
1. Description

2. Testing Parameter /Procedure

HISTORY OF REVIEW
Date Previous Revision No. CCF No. if any Reason for Review

--- PREPARED BY CHECKED BY APPROVED BY AUTHORISED BY

Designation
Name
Sign. & Date

--- PREPARED BY CHECKED BY APPROVED BY AUTHORISED BY

Designation Officer-QC/Designee HOD –QC-Designee HOD –QA/Designee Plant Head
Sign.
Date
Name
FORMAT NO. : HH-III/QA/001/F-01/00
COMPANY CONFIDENTIAL
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COMPANY CONFIDENTIAL
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ANNEXURE NO-XI
INPROCESS SAMPLE ANALYTICAL WORK SHEET

INPROCESS SAMPLE ANALYTICAL WORK SHEET

AWR NO. Effective Date
Review Before
NAME OF INPROCESS SAMPLE
Revison Number
Page
02 of -----

IUSSED BY
Product Name:
Batch No. Batch Size
MFG Date: EXP. Date:
A.R.No: Date of Analysis completed:
Specification No.:. Standard test procedure:
1.0 Description

Specification

Observation_____________________________________________________________________________

Analysed by___________________ Checked by________________________

2.0 Test parameter

Instrument ID NO. _________________ Calibration Due to_________________

Balance ID NO. __________________ Calibration Due to_________________

Acceptance Criteria:
Complies/ does not comply

Analysed by__________________ Checked by________________________

--- PREPARED BY CHECKED BY APPROVED BY

Designation
Name
Sign. & Date

Format No.: HH-III\QC\008\F-11\00

COMPANY CONFIDENTIAL
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--- PREPARED BY CHECKED BY APPROVED BY AUTHORISED BY
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Sign.
Date
Name
FORMAT NO. : HH-III/QA/001/F-01/00
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ANNEXURE NO-XII
PACKAGING MATERIAL SAMPLE SPECIFICATION

PACKAGING MATERIAL SAMPLE SPECIFICATION

Specification
Effective Date
Number
NAME OF PACKAGING
Review Before
Revison Number MATERIAL
Page
Item Code 02 of -----

S.No TEST

HISTORY OF REVIEW
Date Previous Revision No. CCF No. if any Reason for Review

--- PREPARED BY CHECKED BY APPROVED BY

Designation
Name
Sign. & Date
Format No.: HH-III\QC\008\F-12\00
COMPANY CONFIDENTIAL
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ANNEXURE NO-XIII
PACKAGING MATERIAL STANDARD TEST PROCEDURE

PACKAGING MATERIAL STANDARD TEST PROCEDURE

STP NO. Effective Date
Revision Number NAME OF PACKAGING Review Before
MATERIAL
Item Code Page
02 of -----
1. Description

2. Testing Parameter

3. Testing Parameter
--- PREPARED BY CHECKED BY APPROVED BY AUTHORISED BY
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Sign.
Date
Name
FORMAT NO. : HH-III/QA/001/F-01/00
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4. Testing Parameter

--- PREPARED BY CHECKED BY APPROVED BY

Designation
Name
Sign. & Date
Format No.: HH-III\QC\008\F-13\00
COMPANY CONFIDENTIAL
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ANNEXURE NO-XIV

PACKAGING MATERIAL ANALYTICAL WORK SHEET

PACKAGING MATERIAL ANALYTICAL WORK SHEET

AWR NO. Effective Date
Item Code NAME OF PACKAGING Review Before
MATERIAL
Revison Number Page 02 of -----

IUSSED BY
Material Name:
Batch NO. Quantity Recived:
Mfged by: Supplied by:
GRN No.: Recived Date:
A.R.No: Date of Anlaysis completed:
Specification No.:. Standard test procedure:
1.0 Description

Specification

Observation_____________________________________________________________________________

____________________________________________________________________________________

Analysed by___________________ Checked by________________________

2.0Test parameter
Instrument ID NO. _________________ Calibration Due to_________________

Balance ID NO. __________________ Calibration Due to_________________

--- PREPARED BY CHECKED BY APPROVED BY AUTHORISED BY

Designation Officer-QC/Designee HOD –QC-Designee HOD –QA/Designee Plant Head
Sign.
Date
Name
FORMAT NO. : HH-III/QA/001/F-01/00
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Solution Preparation Record

Sr.NO Laboratory Solution Preparation NO. Validity

Procedure:
Acceptance Criteria:

Complies/ does not comply

Analysed by___________________ Checked by________________________

Format No.: HH-III\QC\008\F-14\00

COMPANY CONFIDENTIAL
Uncontrolled copy if QA stamp is not red

ANNEXURE NO-IV
MISCELLANEOUS ITEM SPECIFICATION

MISCELLANEOUS ITEM SPECIFICATION

Specification
Effective Date
Number Name of Raw Material
Revison Number Review Before
Item Code Page
01 of -----
Name of the material
Category
Chemical Name (INN Name) International
Nonproprietary Name
CAS No
Molecular formula
Molecular weight
Storage

--- PREPARED BY CHECKED BY APPROVED BY AUTHORISED BY

Designation

--- PREPARED BY CHECKED BY APPROVED BY AUTHORISED BY

Designation Officer-QC/Designee HOD –QC-Designee HOD –QA/Designee Plant Head
Sign.
Date
Name
FORMAT NO. : HH-III/QA/001/F-01/00
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Name
Sign. & Date

Format.: HH-III\QC\008\F-15\00
COMPANY CONFIDENTIAL
Uncontrolled copy if QA stamp is not red

MISCELLANEOUS ITEM SPECIFICATION

Specification
NAME OF Effective Date
Number
MISCELLANEOUS ITEM
Revison Number Review Before
Item Code Page
02 of -----

S.No TEST

HISTORY OF REVIEW
Date Previous Revision No. CCF No. if any Reason for Review

--- PREPARED BY CHECKED BY APPROVED BY AUTHORISED BY

Designation
Name
Sign. & Date

COMPANY CONFIDENTIAL
Uncontrolled copy if QA stamp is not red

ANNEXURE NO-V
MISCELLANEOUS ITEM STANDARD TEST PROCEDURE

MISCELLANEOUS ITEM STANDARD TEST PROCEDURE

STP NO. Effective Date
NAME OF
MISCELLANEOUS ITEM Review Before
Revison Number

--- PREPARED BY CHECKED BY APPROVED BY AUTHORISED BY

Designation Officer-QC/Designee HOD –QC-Designee HOD –QA/Designee Plant Head
Sign.
Date
Name
FORMAT NO. : HH-III/QA/001/F-01/00
COMPANY CONFIDENTIAL
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Item Code Page

02 of -----
1. Description

2. Solubility
3. Identification
4. Testing Parameter/Procedure

HISTORY OF REVIEW
Date Previous Revision No. CCF No. if any Reason for Review

--- PREPARED BY CHECKED BY APPROVED BY AUTHORISED BY

Designation
Name
Sign. & Date
Format.: HH-III\QC\008\F-16\00
COMPANY CONFIDENTIAL
Uncontrolled copy if QA stamp is not red

ANNEXURE NO-XVI
MISCELLANEOUS ITEM ANALYTICAL WORK SHEET

MISCELLANEOUS ITEM ANALYTICAL WORK SHEET

GTP Effective Date
Item Code NAME OF MISCELLANEOUS Review Before
ITEM
Revison Number Page 02 of -----

MISCELLANEOUS ITEM ANALYTICAL WORKSHEET

IUSSED BY
Material Name:
Batch NO. Quantity Recived:
MFG Date: EXP. Date:
Mfged by: Supplied by:
GRN No.: Recived Date:
A.R.No: Date of Anlaysis completed:
Specification No.:. Standard test procedure:
1.0 Description

--- PREPARED BY CHECKED BY APPROVED BY AUTHORISED BY

Designation Officer-QC/Designee HOD –QC-Designee HOD –QA/Designee Plant Head
Sign.
Date
Name
FORMAT NO. : HH-III/QA/001/F-01/00
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Uncontrolled copy if QA stamp is not red
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Specification

Observation_____________________________________________________________________________

____________________________________________________________________________________

Analysed by___________________ Checked by________________________

____________________________________________________________________________________

Complies/ does not comply

Analysed by___________________ Checked by________________________

2.0Test parameter
Instrument ID NO. _________________ Calibration Due to_________________

Balance ID NO. __________________ Calibration Due to_________________

Solution Preparation Record

Sr.NO WS/RS/Reagent/Solvent WS No./Batch NO./LOT No Validity

Sr.NO Laboratory Solution Preparation NO. Validity

Procedure:

Acceptance Criteria:

Complies/ does not comply

Analysed by___________________ Checked by________________________

Format No.:HH-III\QC\008\F-17\00

COMPANY CONFIDENTIAL
Uncontrolled copy if QA stamp is not red
--- PREPARED BY CHECKED BY APPROVED BY AUTHORISED BY
Designation Officer-QC/Designee HOD –QC-Designee HOD –QA/Designee Plant Head
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Name
FORMAT NO. : HH-III/QA/001/F-01/00
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GENERAL TEST PROCEDURE

AWR NO. Effective Date
NAME OF GENERAL TEST Review Before
PROCEDURE
Revison Number Page 01 of -----

Test Parameters & Procedure

--- PREPARED BY CHECKED BY APPROVED BY

Designation
Name
Sign. & Date

FORMAT NO. : HH-III\QC\008\F-18\00

ANNEXURE –XIX
Justification of re issuance of analytical work sheet

HIGGS HEALTHCARE Unit III

Khasra No.1013,1014,1015/672/449Vill. Dharampur Baddi Distt Solan HP
173205 India
QUALITY CONTROL DEPARTMENT

Name of Product /ITEM

Batch No
Analytical Work sheet No.
1st copy issued on
1st copy issued to
Name sign and Date
Reason of Issuance

Page no
Requested by
Name sign and Date

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Date
Name
FORMAT NO. : HH-III/QA/001/F-01/00
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Approved By
Name sign and Date
Re issued on
Re issued by
Name sign and Date
Re issued to
Name sign and Date
FORMAT NO. : HH-III\QC\008\F-19\00
COMPANY CONFIDENTIAL
Uncontrolled copy if QA stamp is not red

ANNEXURE No - XIX
STS/STP/GTP ISSUANCE AND RETRIEVAL REGISTER

STS/STP/GTP ISSUANCE AND RETRIEVAL REGISTER

Title of
Date of STS/STP/ Revision Issue No./ Issued Received Retrieved Destruction
STS/STP/
Issue GTS/GTP No. No. Copy No. By By QC By QA Done By
GTS/GTP

FORMAT NO. : HH-III\QC\008\F-20\00

COMPANY CONFIDENTIAL
Uncontrolled copy if QA stamp is not red

--- PREPARED BY CHECKED BY APPROVED BY AUTHORISED BY

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Date
Name
FORMAT NO. : HH-III/QA/001/F-01/00
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ANNEXURE No - XX
ANALYTICAL WORKSHEET ISSUANCE AND RETRIEVAL REGISTER

ANALYTICAL WORKSHEET ISSUANCE AND RETRIEVAL REGISTER

Title of
Date of STS/STP/ Revision Issue No./ Issued Received Retrieved Destruction
STS/STP/
Issue GTS/GTP No. No. Copy No. By By QC By QA Done By
GTS/GTP

FORMAT NO. : HH-III/QC/008/F-20/00

END OF SOP

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Name
FORMAT NO. : HH-III/QA/001/F-01/00
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