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Wednesday, November 26, 2008

Pharmaceutical product information manual Pharma dossier

Pharmaceutical product information manual (Pharmaceutical product dossier) for registration of your pharmaceutical product to foreign countries
whoguideline.blogspot.com gives you a sample document for your reference :-

Dear friends , if you are engaged in making lot of pharmaceutical product information manuals Pharmaceutical Product dossiers , i have a very good sample document which my UK based pharmaceutical company which has used to register the product to lot of countries around the world.
Here is the link for word file for Pharmaceutical product information manuals Pharmaceutical Product dossiers, you can copy this and use it for your product.
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What are the important points which one should cover in the product information manual

Pharmaceutical Product dossiers, is that all technical information about the pharmaceutical product , as well as all technical information of active ingredient .

Here are the points in brief for following pharmaceutical .

Ampicillin Sodium for Injection B.P. 250 mg.

1. Name of Applicant : XYZ PVT LTD

2. Address : abcd
3. Status of Applicant : Importer / Local Agent
4. Manufacturing unit : Address USA.
5. Name of THE Drug : Ampicillin Sodium for Injection B.P. 250 mg.
6. Brand Name ( if any) :
7 Official or approved name : AMPICILLIN SODIUM FOR INJECTION B.P 250MG
8. Dosage Form of the drug : Sterile Powder for Reconstitution and injection.
6. COMPOSITION OF THE PRODUCT : Each vial contains: Ampicillin Sodium B.P. equivalent to Ampicillin 250 mg.
7. Pharmacological Group OF THE Drug : Penicillins ( Antibacterials)
8. CERTIFICATE FROM THE HEALTH AUTHORITIES:
a. VALID MANUFACTURING LICENSE enclose these documents
b. FREE SALE CERTIFICATE
c. WHO GMP CERTIFICATE

9.Published Reports on Controlled Clinical Trials Establishing the Therapeutic Efficacy of the Drug
10. Summary of toxicity tests and tests for teratogenacity indicating the safety of the drug.
ACUTE TOXICITY STUDIES & OVERDOSAGE
SUB ACUTE AND CHRONIC TOXICITY STUDIES
Reproduction and Teratogenicity
SAFETY DURING PREGNANCY AND LACTATION
11.PHARMACOLOGY
a) PHARMACOLOGICAL ACTION
PHARMACODYNAMICS
PHARMACOKINETICS AND BIOAVAILABILITY
INACTIVATION IN BODY
DISTRIBUTION OF THE DRUG IN BODY :
THERAPEUTIC INDICATIONS
12. CLINICAL INFORMATION

a) INDICATIONS
b) CONTRAINDICATIONS
c) PRECAUTIONS
d) WARNINGS
e) ADVERSE EFFECTS
f) DRUG INTERACTION
g) DOSAGE
h) OVER DOSAGE AND ANTIDOTE
13. PHARMACEUTICAL INFORMATION
a) DOSAGE FORM
b) PACK SIZE
c) STORAGE CONDITIONS
d) SHELF LIFE
14. MANUFACTURING
a) MASTER MANUFACTURING FORMULA
Quantitative Formula
Equipments Used
Precautions
b) METHOD OF MANUFACTURING
c) IN PROCESS CONTROLS AND PRECAUTIONS
1. Cleaning & Control of the Area
2. Cleaning of Equipment
3. Calibration of Instruments
4. Controls of important manufacturing operations
5. Visual Inspection of Finished Vials
6. Control during packing
d) VALIDATION OF IMPORTANT MANUFACTURING OPERATIONS PHARMA PROCESS VALIDATIONS
1. Line clearance approval by quality control prior to Manufacturing and packaging procedures.

2. Step wise processing as per the Standard Operating Procedures.

3. Check release reference of all Raw material and Primary Packaging material.

a) Record of specified weight of raw material, which includes the Gross weight, Net weight and the Tear weight.
b) Packing material quantity.

4. Washing : Check the washed vials for its effective cleaning. The vials must be free
from particles, fibres and any other foreign material.

5. Sterilization of primary packaging material components, equipments, uniforms and gloves.

6. Vial filling :
a) Fill weight variation and uniformity of weight per vial.
b) Seal integrity.

7. Visual Checking of the vials for the following:

a) Foreign particles
b) Glass particles
c) Presence of stopper
d) Effective sealing/Seal rejection
e) Any other defects

A record of the good vials and the rejected vials must be made.

8. In process sampling, analysis and approval by the Quality control at every stage of the production and the respective records should be maintained.

9. Each container containing the product at various stages of the manufacturing process are appropriately labeled and identified.

10.Checking of correct secondary packing material and the overprinted details.

11. Content of Inner Pack and Final Pack

12. Microbial Contamination, Humidity & Temperature Control in the Manufacturing/Packing area.
13. Reconciliation for the finished product & packing material.

14. Validation of finished product
15. CONTROLS
a)RAW MATERIALS SPECIFICATIONS & CONTROLS
b) PACKING SPECIFICATIONS & CONTROLS
C) METHOD OF ANALYSIS
A SUMMARY OF CONTROLS OF INTERMEDIATE PRODUCTS WITH TEST METHODS AND SPECIFICATIONS
Analytical Control Procedures performed during the manufacturing process. (In process Controls)

1. DURING MANUFACTURING AND FILLING


a) Target fill wt : Every ½ hour (QA and production)
b) Fill wt variation : Every 1 hour (QA and production)
c) Vial sealing : Every 1 hour (QA and production)
d) Filling room temperature : Every 1 hour (QA and production)
e) Filling room humidity : Every 1 hour (QA and production)
f) Description : A white powder, filed into USP type 3 flint vial
and capped with Grey Butyl rubber stopper (20 mm) and
plain aluminium tear off seal (20 mm).
g) Vial size : 7.5 ml.

2. IN PROCESS CHECKS DURING PACKING

a) Mode of Packing
b) Number of units of dosage form per pack
c) Vial Sealing
d) Over printing instructions on primary / Secondary and shipper
e) Excessive gum presence
f) Number of units per shipper
g) Label descriptions and print matter
h) Sticking of label
i) Temperature
j) Relative Humidity
c) FINISHED PRODUCT SPECIFICATIONS & CONTROLS
AMPICILLIN SODIUM FOR INJECTION B.P. 250 mg
Each vial contains
Ampicillin Sodium B.P.
Equivalent to Ampicillin 250 mg
This product conforms to the specification of British Pharmacopoeia 2001
A. STANDARDS AND LIMITS
Description : A white powder filled into USP type 3 flint vial and
capped with grey butyl rubber stopper (20 mm) and plain Aluminium tear off seal (20 mm)

Identification : Should be positive for Ampicillin Sodium

Target fill weight : 265.75 mg

Average fill weight : ± 2 % of target fill weight 260 44 to 271.07 mg

Vial size : 7.5 ml

Alkalinity : pH of a solution containing the equivalent of 10% w/v
of ampicillin, 8.0 to 10.0, Appendix V L, measured within 10 minutes of preparing the solution.

Iodine absorbing Substances : The sum of the percentage of iodine-absorbing
substances and that of ampicillin sodium, both
calculated with reference to the anhydrous material, is not less than 97.5%

Water : NMT 2.0% w/w

Assay : 95.0 % to 105.0 %
B. METHOD OF ANALYSIS FINISHED PRODUCT
16. STABILITY REPORT
REAL TIME AND ACCELERATED STABILITY DATA
STABILITY REPORT
REAL TIME AND ACCELERATED STABILITY DATA
17. CERTIFICATE OF ANALYSIS
18. LIST OF COUNTRIES
In which the Drug is Approved / Registered for Sale
19. SPECIMEN OF THE LABEL : used on the Carton and Vial
20. SPECIMEN OF THE LEAFLET
21. FULLY PACKED SAMPLES OF THE DRUG :in the form offered for sale
Here is the link for word file for Pharmaceutical product information manuals Pharmaceutical Product dossiers, you can copy this and use it for your product.with respect to WHO gmp guidelines whoguidelines.
I have given lots of informative documents for pharmaceutical manufacturing firm which includes
Water purification system guidelines pharma process validations validation protocol with a link to actual word file.
Product validation guidelines validations validation protocol with a link to actual a word file.
Cleaning and sanitation guidelines validations validation protocol with a link to actual word file.
Change control documents a actual sample of a Change control documents
SOPS for microbiology department there is a link to word file which will give you almost all SOPS in microbiology department.
Quality assuarance guide for pharmaceuticals manufacturing
Q.A guide for pharmaceuticals manufacturing
Good manufacturing practice guide for pharmaceuticals manufacturing
see my earlier posts which are having lots of quality assurance documents requirements as per who gmp requirements you will find them very useful.
Keep reading this blog for cGMP and WHO GMP requirements SOP Validations Master Manufacturing documents sample Change control procedure and format water purification system and its validations cleaning validations ,personnel hygiene and guidelines for gmp microbiological procedure SOPS and manufacturing procedures for pharmaceutical dosage forms Master validation plan sample copy and for your WHO GMP requirements
good manufacturing practice guide for pharmaceuticals manufacturing
Quality assuarance guide for pharmaceuticals manufacturing
Q.A guide for pharma
Pharmaceuticals manufacturing guide
Email this blog to your friends or collegues who are working in a pharmaceutical manufacturing firm

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