Scribd
Upload
110 views71 pages

Current Good Manufacturing Practices (GMP) Certificates

The document outlines a list of 40+ items needed for product registration and evaluation. It includes current good manufacturing practices certificates, product samples, technical documents, stability test reports, batch manufacturing formulas, certificates of analysis for raw materials and finished products, and accelerated and real time stability data for multiple batch numbers. Registration certificates and documents are also listed for three Ayurvedic products.

Uploaded by

K-Ayurveda Welex
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
110 views71 pages

Current Good Manufacturing Practices (GMP) Certificates

The document outlines a list of 40+ items needed for product registration and evaluation. It includes current good manufacturing practices certificates, product samples, technical documents, stability test reports, batch manufacturing formulas, certificates of analysis for raw materials and finished products, and accelerated and real time stability data for multiple batch numbers. Registration certificates and documents are also listed for three Ayurvedic products.

Uploaded by

K-Ayurveda Welex
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
You are on page 1/ 71

1.

Current Good
Manufacturing Practices
(GMP) Certificates

2.

To be checked at your
end

3.

All General Documents


for Evaluation

4&
5.

Sample for Products


Dossier
& Technical Document
Evaluation

6. Registration Certificates
for Products

7.

Letter of Authorization
from the Manufacturer

8.

To be checked at your

end

9.

Products Sample

10 Specimen of Label and


.
Aluminium Foil

11
.

Product Profile

12
.

Quality Profile

13
.

Pharmacological
Documents

14
.

Company Profile

15
.

Manufacturing License

16
Certificates of the
. Pharmaceuticals Products
(Copp)

17 &
18.

TIN Certificate

17 &
18a.

IEC Certificate

19.

Manufacturing
Process

20 Certificate of Analysis of
.
Raw Materials

21 Certificate of Analysis of
.
Finished Products

22
.

Disintegration and
Dissolution Profile

23

Stability Test Report

24
.

Package Information

25 Certificate of Analysis of
.
Package and Label

26
.

Bioequivalence Study
Report

27
.

Analytical Method for


Finished Product

28
.

Therapeutic Indication
Product Information
Summary

29 Comparative Dissolution
.
Study Report

30
.

Batch Manufacturing
Formula

31 Sample of Product Each


.

32 Sample of Products Cover


.
Each

33
.

Product Price List

34
.

Product Code

35
.

To be checked at your
end

36

To be checked at your

end

37
.

To be checked at your
end

38
.

Spiral Binding for Each


Product

39
.

To be checked at your
end

40
.

CD Copy

Accelerated Time
Batch Nos. 256, 257 &
258

Real Time
Batch Nos. 256, 257 &
258

Accelerated Time
Batch Nos. 245, 246 &
247

Real Time
Batch Nos. 245, 246 &
247

Accelerated Time
Batch Nos. 205, 206 &
207

Real Time
Batch Nos. 205, 206 &
207

Accelerated Time
Batch Nos. 129, 130 &
131

Real Time
Batch Nos. 129, 130 &
131

Accelerated Time
Batch Nos. 232, 233 &

234

Real Time

Batch Nos. 232, 233 &


234

Accelerated Time
Batch Nos. 132, 133 &
134

Real Time
Batch Nos. 132, 133 &
134

Accelerated Time
Batch Nos. 181, 182 &
183

Real Time
Batch Nos. 181, 182 &
183

Accelerated Time
Batch Nos. 291, 292 &
293

Real Time
Batch Nos. 291, 292 &
293

Accelerated Time
Batch Nos. 221, 222 &
223

Real Time
Batch Nos. 221, 222 &
223

Accelerated Time
Batch Nos. 141, 142 &
143

Real Time
Batch Nos. 141, 142 &
143

Accelerated Time
Batch Nos. 129, 130 &
131

Real Time
Batch Nos. 129, 130 &
131

Accelerated Time
Batch Nos. 247, 248 &
249

Real Time
Batch Nos. 247, 248 &
249

Accelerated Time
Batch Nos. 217, 218 &

219

Real Time

Batch Nos. 217, 218 &


219

Registration Documents of
K-Ayurveda Ayulax,

K-Ayurveda Ayulite,
K-Ayurveda Ayuvita (Forte)

You might also like