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Addendum

The document outlines addendums for various pharmaceutical products, detailing changes in specifications and testing parameters for each product. Key products include Fungnil Cream, No Sores Gel, and others, with revisions indicating updates in testing parameters such as average fill weight, assay, and microbial counts. Stability studies are noted to be conducted at specified intervals for microbiological testing.

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stabilityroom321
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2 views19 pages

Addendum

The document outlines addendums for various pharmaceutical products, detailing changes in specifications and testing parameters for each product. Key products include Fungnil Cream, No Sores Gel, and others, with revisions indicating updates in testing parameters such as average fill weight, assay, and microbial counts. Stability studies are noted to be conducted at specified intervals for microbiological testing.

Uploaded by

stabilityroom321
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd

TORQUE PHARMACEUTICAL PVT.

LTD-UNIT-1 (DAPPAR)

TITLE :- Addendum for Specification & Stp of Fungnil Cream

Existing Specification Details Current Specification Details


Product Name Specification Revision Specification Revision
Testing Parameters Testing Parameters
No. No. No. No.
1. Description
2. Identification
1. Description 3. Minimum fill weight
2. Identification 4. 2-Chlorotritanol
Fungnil Cream 3. Minimum fill weight (Impurity A)
SP/FPEP-F02/08 08 SP/FPEP-F02/09 09
(Clotrimazole Cream) 4. 2-Chlorotritanol 5. Total Aerobic microbial
(Impurity A) count
5. Assay Yeast and moulds count
Pathogen
6. Assay

[Note-During Stability Study Microbiological testing conducted at Initial, 12 Month, 24 Month / 36 Month]

Prepared By Reviewed By Approved By


Name
Designation
Sign. /Date

Page 1 of 1
TORQUE PHARMACEUTICAL PVT. LTD-UNIT-1 (DAPPAR)

TITLE :- Addendum for Specification & Stp of No Sores Gel

Existing Specification Details Current Specification Details


Product Name Specification Revision Specification Revision
Testing Parameters Testing Parameters
No. No. No. No.
1. Description
2. Identification
1. Description 3. pH
No Sores Gel
2. Identification 4. Average fill weight
(Lignocaine
SP/FPEP-N05/07 07 3. pH SP/FPEP-N05/09 09 5. Assay
Hydrochloride &
4. Average fill weight 6. Total Aerobic microbial
Choline Salicylate gel)
5. Assay count
Yeast and moulds count
Pathogen

[Note-During Stability Study Microbiological testing conducted at Initial, 12 Month, 24 Month / 36 Month]

Prepared By Reviewed By Approved By


Name
Designation
Sign. /Date

Page 1 of 1
TORQUE PHARMACEUTICAL PVT. LTD-UNIT-1 (DAPPAR)

TITLE :- Addendum for Specification & Stp of Fungnil-B Cream

Existing Specification Details Current Specification Details


Product Name Specification Revision Specification Revision
Testing Parameters Testing Parameters
No. No. No. No.
1. Description
2. Identification
Fungnil-B Cream 1. Description 3. Average fill weight
(Clotrimazole & 2. Identification 4. Assay
SP/FPEP-F03/08 08 SP/FPEP-F03/09 09
Beclomethasone 3. Average fill weight 5. Total Aerobic microbial
Dipropionate Cream) 4. Assay count
Yeast and moulds count
Pathogen

[Note-During Stability Study Microbiological testing conducted at Initial, 12 Month, 24 Month / 36 Month]

Prepared By Reviewed By Approved By


Name
Designation
Sign. /Date

TITLE :- Addendum for Specification & Stp of Skinncare Ointment


Page 1 of 1
TORQUE PHARMACEUTICAL PVT. LTD-UNIT-1 (DAPPAR)

Existing Specification Details Current Specification Details


Product Name Specification Revision SpecificationRevision
Testing Parameters Testing Parameters
No. No. No. No.
1. Description
2. Identification
Skinncare Ointment 1. Description 3. Average fill weight
(Clobetasole 2. Identification 4. Assay
SP/FPEP-S02/00 00 SP/FPEP-S02/00 01
Propionate & Salicylic 3. Average fill weight 5. Total Aerobic microbial
acid Ointment) 4. Assay count
Yeast and moulds count
Pathogen

[Note-During Stability Study Microbiological testing conducted at Initial, 12 Month, 24 Month / 36 Month]

Prepared By Reviewed By Approved By


Name
Designation
Sign. /Date

TITLE :- Addendum for Specification & Stp of Winderm Cream

Page 1 of 1
TORQUE PHARMACEUTICAL PVT. LTD-UNIT-1 (DAPPAR)

Existing Specification Details Current Specification Details


Product Name Specification Revision Specification Revision
Testing Parameters Testing Parameters
No. No. No. No.
1. Description
2. Identification
Winderm Cream
1. Description 3. Average fill weight
(Clobetasole,
2. Identification 4. Assay
Neomycin & SP/FPEP-W01/08 08 SP/FPEP-W01/09 09
3. Average fill weight 5. Total Aerobic microbial
Beclomethasone
4. Assay count
Cream)
Yeast and moulds count
Pathogen

[Note-During Stability Study Microbiological testing conducted at Initial, 12 Month, 24 Month / 36 Month]

Prepared By Reviewed By Approved By


Name
Designation
Sign. /Date

TITLE :- Addendum for Specification & Stp of Glygesic Rheumetic Cream

Product Name Existing Specification Details Current Specification Details


Page 1 of 1
TORQUE PHARMACEUTICAL PVT. LTD-UNIT-1 (DAPPAR)

Specification Revision Specification Revision


Testing Parameters Testing Parameters
No. No. No. No.
1. Description
2. Identification
1. Description 3. Average fill weight
Glygesic Forte 2. Identification 4. Assay
SP/FPEP-G01/08 08 SP/FPEP-G01/09 09
Rheumetic Cream 3. Average fill weight 5. Total Aerobic microbial
4. Assay count
Yeast and moulds count
Pathogen

[Note-During Stability Study Microbiological testing conducted at Initial, 12 Month, 24 Month / 36 Month]

Prepared By Reviewed By Approved By


Name
Designation
Sign. /Date

TITLE :- Addendum for Specification & Stp of Burn Cur Cream

Product Name Existing Specification Details Current Specification Details


Specification Revision Testing Parameters Specification Revision Testing Parameters
Page 1 of 1
TORQUE PHARMACEUTICAL PVT. LTD-UNIT-1 (DAPPAR)

No. No. No. No.


1. Description
2. Identification
1. Description 3. Average fill weight
Burn Cur Cream
2. Identification 4. Assay
[Acriflavine & SP/FPEP-B01/08 08 SP/FPEP-B01/09 09
3. Average fill weight 5. Total Aerobic microbial
Thymol Cream]
4. Assay count
Yeast and moulds count
Pathogen

[Note-During Stability Study Microbiological testing conducted at Initial, 12 Month, 24 Month / 36 Month]

Prepared By Reviewed By Approved By


Name
Designation
Sign. /Date

TITLE :- Addendum for Specification & Stp of Dress Up Cream

Existing Specification Details Current Specification Details


Product Name Specification Revision Specification Revision
Testing Parameters Testing Parameters
No. No. No. No.
Page 1 of 1
TORQUE PHARMACEUTICAL PVT. LTD-UNIT-1 (DAPPAR)

1. Description
2. Identification
1. Description 3. Average fill weight
Dress Up Cream
2. Identification 4. Assay
[Neomycin Sulphate SP/FPEP-D02/08 08 SP/FPEP-D02/09 09
3. Average fill weight 5. Total Aerobic microbial
Cream]
4. Assay count
Yeast and moulds count
Pathogen

[Note-During Stability Study Microbiological testing conducted at Initial, 12 Month, 24 Month / 36 Month]

Prepared By Reviewed By Approved By


Name
Designation
Sign. /Date

TITLE :- Addendum for Specification & Stp of Burnex Cream

Existing Specification Details Current Specification Details


Product Name Specification Revision Specification Revision
Testing Parameters Testing Parameters
No. No. No. No.
Burnex Cream SP/FPEP-B02/07 07 1. Description SP/FPEP-B02/08 08 1. Description
Page 1 of 1
TORQUE PHARMACEUTICAL PVT. LTD-UNIT-1 (DAPPAR)

2. Identification
3. Average fill weight
[Silver
2. Identification 4. Assay
Sulphadiazine &
3. Average fill weight 5. Total Aerobic microbial
Chlorhexidine
4. Assay count
Gluconate Cream]
Yeast and moulds count
Pathogen

[Note-During Stability Study Microbiological testing conducted at Initial, 12 Month, 24 Month / 36 Month]

Prepared By Reviewed By Approved By


Name
Designation
Sign. /Date

TITLE :- Addendum for Specification & Stp of Neo-Povidina Ointment

Existing Specification Details Current Specification Details


Product Name Specification Revision Specification Revision
Testing Parameters Testing Parameters
No. No. No. No.
Neo-Povidina SP/FPEP-N01/07 07 1. Description SP/FPEP-N01/08 08 1. Description
Ointment 2. Identification 2. Identification
Page 1 of 1
TORQUE PHARMACEUTICAL PVT. LTD-UNIT-1 (DAPPAR)

3. Average fill weight


4. Assay
[Povidina Iodine 3. Average fill weight 5. Total Aerobic microbial
Ointment] 4. Assay count
Yeast and moulds count
Pathogen

[Note-During Stability Study Microbiological testing conducted at Initial, 12 Month, 24 Month / 36 Month]

Prepared By Reviewed By Approved By


Name
Designation
Sign. /Date

TITLE :- Addendum for Specification & Stp of Neo-Povidina Ointment

Existing Specification Details Current Specification Details


Product Name Specification Revision Specification Revision
Testing Parameters Testing Parameters
No. No. No. No.
Neosten Cream SP/FPEP-N03/07 07 1. Description SP/FPEP-N03/08 08 1. Description
[Clotrimazole 2. Identification 2. Identification
Cream] 3. Average fill weight 3. Average fill weight
Page 1 of 1
TORQUE PHARMACEUTICAL PVT. LTD-UNIT-1 (DAPPAR)

4. Assay
5. Total Aerobic microbial
4. Assay count
Yeast and moulds count
Pathogen

[Note-During Stability Study Microbiological testing conducted at Initial, 12 Month, 24 Month / 36 Month]

Prepared By Reviewed By Approved By


Name
Designation
Sign. /Date

TITLE :- Addendum for Specification & Stp of Neofenac Gel

Existing Specification Details Current Specification Details


Product Name Specification Revision Specification Revision
Testing Parameters Testing Parameters
No. No. No. No.
Neofenac Gel SP/FPEP-N02/07 07 1. Description SP/FPEP-N02/08 08 1. Description
[Diclofenac Gel] 2. Identification 2. Identification
3. Average fill weight 3. Average fill weight
4. Assay 4. Assay
Page 1 of 1
TORQUE PHARMACEUTICAL PVT. LTD-UNIT-1 (DAPPAR)

5. Total Aerobic microbial


count
Yeast and moulds count
Pathogen

[Note-During Stability Study Microbiological testing conducted at Initial, 12 Month, 24 Month / 36 Month]

Prepared By Reviewed By Approved By


Name
Designation
Sign. /Date

TITLE :- Addendum for Specification & Stp of Cipromac-FC Cream

Existing Specification Details Current Specification Details


Product Name Specification Revision Specification Revision
Testing Parameters Testing Parameters
No. No. No. No.
Cipromac-FC SP/FPEP-C03/00 00 1. Description SP/FPEP-C03/01 01 1. Description
Cream 2. Identification 2. Identification
3. Average fill weight 3. Average fill weight
4. Assay 4. Assay
5. Total Aerobic microbial
Page 1 of 1
TORQUE PHARMACEUTICAL PVT. LTD-UNIT-1 (DAPPAR)

count
Yeast and moulds count
Pathogen

[Note-During Stability Study Microbiological testing conducted at Initial, 12 Month, 24 Month / 36 Month]

Prepared By Reviewed By Approved By


Name
Designation
Sign. /Date

TITLE :- Addendum for Specification & Stp of Healthease Cream

Existing Specification Details Current Specification Details


Product Name Specification Revision Specification Revision
Testing Parameters Testing Parameters
No. No. No. No.
Healthease Cream SP/FPEP-H01/08 08 1. Description SP/FPEP-H01/09 09 1. Description
2. Identification 2. Identification
3. Average fill weight 3. Average fill weight
4. Assay 4. Assay
5. Total Aerobic microbial
count
Page 1 of 1
TORQUE PHARMACEUTICAL PVT. LTD-UNIT-1 (DAPPAR)

Yeast and moulds count


Pathogen

[Note-During Stability Study Microbiological testing conducted at Initial, 12 Month, 24 Month / 36 Month]

Prepared By Reviewed By Approved By


Name
Designation
Sign. /Date

TITLE :- Addendum for Specification & Stp of Neofenac Gel

Existing Specification Details Current Specification Details


Product Name Specification Revision Specification Revision
Testing Parameters Testing Parameters
No. No. No. No.
Neofenac Gel SP/FPEP-N02/07 07 1. Description SP/FPEP-N02/08 08 1. Description
[Diclofenac Gel] 2. Identification 2. Identification
3. Average fill weight 3. Average fill weight
4. Assay 4. Assay
5. Total Aerobic microbial
count
Yeast and moulds count
Page 1 of 1
TORQUE PHARMACEUTICAL PVT. LTD-UNIT-1 (DAPPAR)

Pathogen

[Note-During Stability Study Microbiological testing conducted at Initial, 12 Month, 24 Month / 36 Month]

Prepared By Reviewed By Approved By


Name
Designation
Sign. /Date

TITLE :- Addendum for Specification & Stp of Threeclotrim Cream

Existing Specification Details Current Specification Details


Product Name Specification Revision Specification Revision
Testing Parameters Testing Parameters
No. No. No. No.
1. Description
2. Identification
1. Description 3. Average fill weight
2. Identification 4. Assay
Threeclotrim Cream SP/FPEP-T01/08 08 SP/FPEP-T01/09 09
3. Average fill weight 5. Total Aerobic microbial
4. Assay count
Yeast and moulds count
Pathogen
Page 1 of 1
TORQUE PHARMACEUTICAL PVT. LTD-UNIT-1 (DAPPAR)

[Note-During Stability Study Microbiological testing conducted at Initial, 12 Month, 24 Month / 36 Month]

Prepared By Reviewed By Approved By


Name
Designation
Sign. /Date

TITLE :- Addendum for Specification & Stp of Diclomac Gel

Existing Specification Details Current Specification Details


Product Name Specification Revision Specification Revision
Testing Parameters Testing Parameters
No. No. No. No.
1. Description
2. Identification
1. Description 3. Average fill weight
2. Identification 4. Assay
Diclomac Gel SP/FPEP-D04/01 01 SP/FPEP-D04/02 02
3. Average fill weight 5. Total Aerobic microbial
4. Assay count
Yeast and moulds count
Pathogen

Page 1 of 1
TORQUE PHARMACEUTICAL PVT. LTD-UNIT-1 (DAPPAR)

[Note-During Stability Study Microbiological testing conducted at Initial, 12 Month, 24 Month / 36 Month]

Prepared By Reviewed By Approved By


Name
Designation
Sign. /Date

TITLE :- Addendum for Specification & Stp of Medisalic Ointment

Existing Specification Details Current Specification Details


Product Name Specification Revision SpecificationRevision
Testing Parameters Testing Parameters
No. No. No. No.
1. Description
2. Identification
1. Description 3. Average fill weight
2. Identification 4. Assay
Medisalic Ointment SP/FPEP-M02/04 04 SP/FPEP-M02/05 05
3. Average fill weight 5. Total Aerobic microbial
4. Assay count
Yeast and moulds count
Pathogen

Page 1 of 1
TORQUE PHARMACEUTICAL PVT. LTD-UNIT-1 (DAPPAR)

[Note-During Stability Study Microbiological testing conducted at Initial, 12 Month, 24 Month / 36 Month]

Prepared By Reviewed By Approved By


Name
Designation
Sign. /Date

TITLE :- Addendum for Specification & Stp of Toractin Tablet

Existing Specification Details Current Specification Details


Product Name Specification Revision Specification Revision
Testing Parameters Testing Parameters
No. No. No. No.
Toractin Tablet SP/FPT-T01/08 08 1. Description SP/FPT-T01/10 10 1. Description
2. Identification 2. Identification
3. Average weight 3. Average weight
4. Uniformity of weight 4. Uniformity of weight
5. Disintegration Time 5. Disintegration Time
6. Friability 6. Friability
7. Dissolution Test 7. Dissolution Test
8. Related Substance 8. Related Substance
9. Hardness 9. Hardness
10. Content Uniformity 10. Content Uniformity
11. Leak Test 11. Leak Test
12. Assay 12. Assay
Page 1 of 1
TORQUE PHARMACEUTICAL PVT. LTD-UNIT-1 (DAPPAR)

13. Total Aerobic microbial


count
Yeast and moulds count
Pathogen

[Note-During Stability Study Microbiological testing conducted at Initial, 12 Month, 24 Month / 36 Month]

Prepared By Reviewed By Approved By


Name
Designation
Sign. /Date

Page 1 of 1

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