| Scale-up experimental batches...GMP Batch approaching the GMP drug product manufacturers.............. updated on May 7, 2005. |
PREPARATION FOR SCALE UP GMP BIOBATCHES
AT MANUFACTURING LABS Zhion, May
2005
The first step is to find out which contract manufacturers are able to manufacture
your clinical or registration batch. Here is an outline of the information that you
should prepare to them for the first contact and obtain a rough idea of the
manufacturing cost:
1. Name of the active ingredient You should also provide the MSDS (toxicity
information) to them. You should mention who will test and release the active
ingredient.
2. A list of all inactive ingredients, And, let them know if you will provide the
materials and who will test and release the materials.
3. A list of equipment needed for the process. You should spell out exactly what type
of equipment, e.g. vertical high shear mixer or horizontal mixer. The granules made
can be very different.
4. Process Outline. You should also include batch size for each step. For
compression, you should mention if you have the toolings.
5. In-process Samples and Experimental Test. If you require them to perform
in-process test before moving to next step (e.g. blend uniformity before
compression, you need to let them know in advance.
6. Stability Test Stability test is a "must" for all clinical trial materials including pilot
batch. You need to let them know if they need to perform such testings.
GMP AUDITING
After you get quotes from various manufacturers, you should initiate a GMP
auditing on these manufacturers including reviewing their FDA citations. There are
fourteen basic questions you should address to them before your inspection on
their facilities:
14 BASIC QUESTIONS FOR THE GMP CONTRACT MANUFACTURERS:
1. Does the facility operate in a state of control as defined by the GMP regulations?
2. Does this facility operate under a facility quality policy?
3. Is its Quality Assurance unit a separate organizational entity
§211.22(a)?
4. Can this Quality Assurance unit approve or reject the products
§211.22(a)?
5. Does the QA unit routinely review batch records §211.22?
6. Are adequate laboratory space, equipment, and personnel to run
testings§211.22(b)?
7. If a contractor is involved, has it been inspected?
8. Date of last inspection:____________________
9. Are all QA procedures and responsibilities in writing§211.22(c)?
10. Are all procedures current and approved?
11. Are the procedures recorded?
12. Are QA supervisory personnel qualified by way of training and experience
§211.25?
13. Are other QA personnel, qualified by way of training and experience §211.25?
14. Has this facilities been inspected by FDA?
15. Did they receive any warning letter (483) from FDA?
If the answers for all these questions are positive, then, you may initiate the GMP
facilities auditing. If you do not have the experience, you should hire qualified GMP
consultant to process the job.
THIS ARTICLE IS FOR YOUR REFERENCE ONLY. YOU SHOULD CONSULT YOUR
GMP CONSULTANTS BEFORE SCALE-UP MANUFACTURING ANY GMP BIOBATCH.
ALL RIGHT RESERVED 2005
AT MANUFACTURING LABS Zhion, May
2005
The first step is to find out which contract manufacturers are able to manufacture
your clinical or registration batch. Here is an outline of the information that you
should prepare to them for the first contact and obtain a rough idea of the
manufacturing cost:
1. Name of the active ingredient You should also provide the MSDS (toxicity
information) to them. You should mention who will test and release the active
ingredient.
2. A list of all inactive ingredients, And, let them know if you will provide the
materials and who will test and release the materials.
3. A list of equipment needed for the process. You should spell out exactly what type
of equipment, e.g. vertical high shear mixer or horizontal mixer. The granules made
can be very different.
4. Process Outline. You should also include batch size for each step. For
compression, you should mention if you have the toolings.
5. In-process Samples and Experimental Test. If you require them to perform
in-process test before moving to next step (e.g. blend uniformity before
compression, you need to let them know in advance.
6. Stability Test Stability test is a "must" for all clinical trial materials including pilot
batch. You need to let them know if they need to perform such testings.
GMP AUDITING
After you get quotes from various manufacturers, you should initiate a GMP
auditing on these manufacturers including reviewing their FDA citations. There are
fourteen basic questions you should address to them before your inspection on
their facilities:
14 BASIC QUESTIONS FOR THE GMP CONTRACT MANUFACTURERS:
1. Does the facility operate in a state of control as defined by the GMP regulations?
2. Does this facility operate under a facility quality policy?
3. Is its Quality Assurance unit a separate organizational entity
§211.22(a)?
4. Can this Quality Assurance unit approve or reject the products
§211.22(a)?
5. Does the QA unit routinely review batch records §211.22?
6. Are adequate laboratory space, equipment, and personnel to run
testings§211.22(b)?
7. If a contractor is involved, has it been inspected?
8. Date of last inspection:____________________
9. Are all QA procedures and responsibilities in writing§211.22(c)?
10. Are all procedures current and approved?
11. Are the procedures recorded?
12. Are QA supervisory personnel qualified by way of training and experience
§211.25?
13. Are other QA personnel, qualified by way of training and experience §211.25?
14. Has this facilities been inspected by FDA?
15. Did they receive any warning letter (483) from FDA?
If the answers for all these questions are positive, then, you may initiate the GMP
facilities auditing. If you do not have the experience, you should hire qualified GMP
consultant to process the job.
THIS ARTICLE IS FOR YOUR REFERENCE ONLY. YOU SHOULD CONSULT YOUR
GMP CONSULTANTS BEFORE SCALE-UP MANUFACTURING ANY GMP BIOBATCH.
ALL RIGHT RESERVED 2005
PHARMCEUTICAL
INDUSTRY
Foundamental
Science
Colloidal
Stabilization
Drug Product
Development
Patent Application
Product
Development
Product
Ingredients
Colorant
Scale up a batch 1
Drug Delivery
Industry
Drug Delivery -
Smart Bomb
Lotion, Cream,
Preps
Enteric
Coating-Eudragit
Enteric
Coating-Nutrateric
SR
Coating-Aquacoat
Drug Industry
Drug
Competitions
Drug in
Development
Cholesterol-lowering
Drug-Terminologies
Packaging
Materials
Market
Drug Dev- 2004
Drug Dev -
2005Q1
Drug Dev- 2005Q2
Drug
Dev-2005Summer
Drug Dev-2005Q3
Orphan Drug
Protein Drug
Niche Market
Novo Norkdisk
R&D
Equipment
Blenders
CONTRACT
MANUFACT.
Nutrition
Supplements
NEW DRUGS
Arranon
Actoplus Met
Alfuzosin
Ambien CR
Avastin
Asmanex(R)
Erbitux
(cetuximab)
Gardasil
GRN163
Herceptin
Increlex (rhIGF-1)
Lidoerm
(Lidocaine)
Liraglutide
Lyrica (pregabalin)
Rozerem
Sorafenib
Sutent
Tamsulosin
Torcetrapib
Zometa
OLD DRUGS
Lithium Carbonate
DRUG NOTES
[CONSTRUCT]
Clinical Research
Terminologies
FDA ALERTS
Protein Drug
Market
Niche Market
Orphan Drug
levothyroxine
Protein Drug 1
Protein Drug2
Double-blind
Study
INDUSTRY
Foundamental
Science
Colloidal
Stabilization
Drug Product
Development
Patent Application
Product
Development
Product
Ingredients
Colorant
Scale up a batch 1
Drug Delivery
Industry
Drug Delivery -
Smart Bomb
Lotion, Cream,
Preps
Enteric
Coating-Eudragit
Enteric
Coating-Nutrateric
SR
Coating-Aquacoat
Drug Industry
Drug
Competitions
Drug in
Development
Cholesterol-lowering
Drug-Terminologies
Packaging
Materials
Market
Drug Dev- 2004
Drug Dev -
2005Q1
Drug Dev- 2005Q2
Drug
Dev-2005Summer
Drug Dev-2005Q3
Orphan Drug
Protein Drug
Niche Market
Novo Norkdisk
R&D
Equipment
Blenders
CONTRACT
MANUFACT.
Nutrition
Supplements
NEW DRUGS
Arranon
Actoplus Met
Alfuzosin
Ambien CR
Avastin
Asmanex(R)
Erbitux
(cetuximab)
Gardasil
GRN163
Herceptin
Increlex (rhIGF-1)
Lidoerm
(Lidocaine)
Liraglutide
Lyrica (pregabalin)
Rozerem
Sorafenib
Sutent
Tamsulosin
Torcetrapib
Zometa
OLD DRUGS
Lithium Carbonate
DRUG NOTES
[CONSTRUCT]
Clinical Research
Terminologies
FDA ALERTS
Protein Drug
Market
Niche Market
Orphan Drug
levothyroxine
Protein Drug 1
Protein Drug2
Double-blind
Study