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Saturday, August 30, 2008

Master manufacturing document in Pharmaceutical Manufacturing

Importance of Master Manufacturing Document in Pharmaceutical Manufacturing:-
As I wrote earlier in my post ,
I am giving below a format of Master Manufacturing Document, it is also called Master Formula Record.Master Manufacturing Document is a very import and piece of document in pharmaceutical manufacturing company.

Master manufacturing document is prepared for a particular product , describing all technical details ,required to do error less manufacturing of a particular product. up on which all validations are done.

It describes in details all points mentioned below.
Also I can send you a sample “Master Manufacturing Document, Formula Master Formula Record ” where you can liberally view, copy and you can use it for your reference , you can do alteration in the details and use it for your self. for your company with respect to WHO guideline


Master Formula Card Master Formula Record


Product Name:-
Product Code:-
Batch Size
Label Claim :
Category:-For Nasal Congestion, common cold & Flu, Headache, Fever & Influenza

Appearance of the tablet eg-
White with blue and pink coloured mosaic appearance, circular, flat, uncoated tablet having breakline on one side.

Shelf - life of the Product
24 months including the month of manufacturing, but not more than the shelf life of the active ingredient used in the batch. In such case the shelf life of the product will be reduced as per the shelf life of the active ingredient.

Note
This Master Formula Card is revised for improvement in the documentation system & no change is authorized without the permission of the undersigned.(Q.A manager/Production Manager/MD)

List of Equipment Required in Manufacturing
List of Instrument Required in Quality Control Department
Specifications of Raw Materials(B.P/USP)
Specifications of Raw Materials
PACKAGING MATERIAL SPECIFICATION
FINISHED PRODUCT – CONFIGURATION
FINISHED PRODUCT SPECIFICATION
MANUFACTURING PROCESS


Precautions

1. Dispensing must be done in the dispensing booth only.
2. Wear nose masks & gloves during dispensing.
3. Put the exhaust fan on during dispensing.
4. Ensure the absence of previous product or batch in the dispensing booth & record the same.
5. Use only calibrated balances for material weighing & check zero error everyday.
6. Dispense one item at a time using clean spatulas & scoops.
7. Dispensing should be done in the presence of 2 qualified persons, 1 from Stores & 1 from Production or QA.
8. Weigh the materials as per the authenticated dispensing Batch Requisition in single poly-bags & put proper label.
9. During weighing check the A.R. No. & Physical Appearance of the material.

STEP 1 : DISPENSING OF RAW MATERIALS

Bill of Material

NOTES

1. Transfer the dispensed material to the manufacturing area and store under controlled temperature and % RH till it is taken for manufacturing.
2. Approximate time required for dispensing is 4 hours.
Manufacturing should start within 48 hours after dispensing

SIFTING : Part A
Preparation of white granules
Precautions
1. Check that the room & the equipment are cleaned & free from previous product or previous B. No. or lot no. of the material.
2. Use nose masks & latex gloves during processing.
3. Put on exhaust during processing.
4. Check the integrity of sifter sieves before & after sifting. Check the integrity of Planetary Mixer (PLM) bowl.
5. Record the previous product & batch no. on the BMR.
6. Put the exhaust fan on during sifting
7. Sift the material in following sequence
Approx. time required for sifting is 40 minutes.
Next step must start within 48 hours.

DRY MIXING
Dry mix the above ingredient in a S.S bowl for 20 mins
BINDER PREPARATION

Precautions
1. Check the A.R. No. & Physical Appearance of Purified Water IP.

Procedure
1. In suitable clean S.S. container take 3.3 L D.M. Water & start heating
2. Dissolve weighed quantity of Sodium Nipagin IP (40gms) and Sodium Nipasol IP (4gms) & PVP K-30 I.P (0.3gms) with stirring . Filter the solution through 100# & reload to the S.S Kettle
3. In seperate S.S container take 2.00 lts of D.M water and make slurry of 1.3 kg of Maize starch I.P (previously sifted through 40 #) by stirring. Ensure that no lumps are formed
4. To the boiling solution in S.S kettle, add the starch slurry from step 3 & stir till homogenous translucent paste is formed
5. Unload the paste in S.S container & allow it to cool to 40-45 °C
6. Record the weight & temperature of paste before adding to the dry mix in PLM bowl.
GRANULATION
Precautions
1. Check that the room & the equipment are cleaned & free from previous product or previous B. No. or lot no. of the material.
2. Use nose masks & latex gloves during processing.
3. Put on exhaust during processing.
4. Check the integrity of PLM bowl, blades before & after granulation.
5. Record the previous product & batch no. on the BMR.

Procedure
1. Dry mix the above sifted ingredients in the Planetary Mixer (PLM) for 15 minutes at slow speed & 5 minutes at fast speed.
2. Add gradually the binder solution to the powder in the PLM bowl. Granulate for 10 minutes.
3. Stop the PLM. Scrap the blades & sides of PLM & continue mixing till a characteristic granular mass is obtained. If required additional Purified Water IP may be added.

Granulation done by: (Operator) Granulation checked by: (Supervisor)

Approx. time required for granulation is 35 minutes.
Next step must start within 1 hr
DRYING
Semidry the wet mass in FBD at 60-70°C till LOD is 4 - 4.2% ( at 105°C for a period of 10 minutes)
SEMIDRYING SIFTING
Sift the semidried mass through 14 mesh on sifter and pass the oversize granules through 2 mm sieve of multimill.
FINAL DRYING
Dry the semidried sifted granules in a FBD at 60-70°C till the loss on drying is 2 - 2.5%
(for a period of 15 - 20 mins)
SIZING
Precautions
1. Check that the room & the equipment are cleaned & free from previous product or previous B. No. Material.
2. Use nose masks & latex gloves during processing.
3. Put on exhaust during processing.
4. Check the integrity of sifter sieve, multi-mill blades before & after sizing.
5. Record the previous product & batch no. on the BMR.
Procedure
1. Pass the dried granules through 14 # sieve on sifter.
2. Pass oversize granules through 2 mm screen of Multi-mill using medium speed & knives forward direction.
3. Collect the granules in the containers lined with single polyethylene bag.
4. Weigh the granules & record the weight.
5. Label the granules properly.
6. Return the granules to Stores for storage & Q.C. analysis.
Weighed by : (Operator) Weight checked by : (Supervisor)
Date : Shift :
Theoretical Yield (Weight) : 99% to 100% Actual Yield (Weight) : kg.
( Theoretical Wt. :26.769 Kg )
Granules returned to Stores on : Released from Q.C. on :


Lubrication

Procedure
1. Sieve the following ingredients in the given sequence only.
2. Collect the sifted material in containers lined with polyethylene bags.
WEIGHING OF LUBRICATED GRANULES

Procedure
1. Collect the blend in containers lined with double polyethylene bag & keep one silica gel bag of 50 gm between the 2 poly-bags.
2. Weigh the blend & record the weight.
3. Label the containers properly as ready for compression.
4. Transfer the blend to quarantine area for storage & Q.C. analysis. Store the blend in cool & dry place.
5. Take for compression only after receiving Q.C. release for compression.
SAMPLING
Procedure
1. After receiving the request from Production dept., the QC person will be deputed for sampling.
2. The person will open all the containers of lubricated blend and will draw about 15-20 gm of sample from each drum of the blend.
3. The composite sample will be analysed as per SOPs & the Production dept. will be intimated for filling.

COMPRESSION
Procedure
1. Adjust the Compression machine for following parameters of the tablets.
2. Check that the correct dies, upper punches and lower punches are taken.
3. Ensure proper fixtures of the dies, upper punches and lower punches using hand wheel provided on the machine.
4. Adjust the speed of the machine ------
5. Ensure proper fixture of the feed frame.
6. Fit the hopper onto the machine and fill the hopper with the blend.
7. Rotate the machine by hand to ensure that all die cavities are properly filled & there is no untoward noise from the machine.
8. Start the machine and adjust the machine for the required physical parameters of the tablet.
9. Check the appearance of the tablets, average weight of 20 tablets, Disintegration time , Harness and thickness of tablets at a frequency mentioned in the table below and record in the BMR .
10. De-dust and collect the tablets in the containers lined with polyethylene bags and label them properly.

Parameters
Frequency
a. Weight of 20 tablets
Every 15 minutes
b. Thickness
Every 15 minutes
c. Disintegration Time
Every 2 hours
d. Friability
Every 2 hours
e. Individual Weight of 30 tablets
Twice a shift including at the start of the machine
f. Hardness
Every 2 hours
WEIGHING

Procedure
1. Collect the tablets in containers lined with double polyethylene bag & keep one silica gel bag of 50 gm between the 2 poly-bags.
2. Weigh the filled tablets & record the weight.
3. Label the containers properly as ready for inspection & polishing.
4. Transfer the filled tablets to quarantine area for storage & Q.C. analysis. Store the filled tablets in cool & dry place.
5. Take for inspection & packing only after receiving Q.C. release for packing.
SAMPLING

Procedure
1. After starting the satisfactory run of the machine, Production dept. will issue a request for analysis to QC dept.
2. The QC person will collect the sample during the actual run of the machine.
3. The composite sample collected during the actual run of the machine will be used for Physical Parameter testing for release of the batch for coating.
INSPECTION

Precautions
1. Check that the room & the equipment are cleaned & free from previous product or previous B. No. material.
2. Use nose masks & hand-gloves during inspection & polishing.
3. Record the previous product & batch no. on the BMR.
4. During inspection & polishing ensure that the room temperature is below 250 ±2°C & % RH is between 40-50%.


1. Collect all the rejections separately & label them properly.
2. The rejection can be reprocessed, either in the same batch or in the subsequent batch as per the SOP for handling recoverable.
3. During inspection, the inspected good tablets should be polished with a non-fibre shredding towel for elegance & for removal of adhering powder.
4. Store the inspected & polished tablets in the containers lined with double polyethylene bags & keep one silica gel bag of 50 gm between the 2 polybags and label the containers properly as ready for packing.
In-Process Quality Control Chart

Date/Time
Room Temp. in 0 C
% RH
Appearance
Wt of 20 tab in gm
(11.7247-12.203g
Thickness in mm
D.T. in min
(nm
Hard
Ness in
(5-10
Kg/cm²
Friability
(NMT 1%)
Checked by
Weight Variation Chart
Actual Weight of 20 tablets : gm
Average Weight of tablet gm

Weight Variation : + 5.0 % (Limit mg to mg)
1. 2. 3. 4. 5.
6. 7. 8. 9. 10.
11. 12. 13. 14. 15.
16. 17. 18. 19. 20.
WEIGHING

Procedure
6. Collect the tablets in containers lined with double polyethylene bag & keep one silica gel bag of 50 gm between the 2 poly-bags.
7. Weigh the tablets & record the weight.
8. Label the containers properly as ready for inspection & polishing.
9. Transfer the tablets to quarantine area for storage & Q.A. analysis. Store the tablets in cool & dry place.
10. Take for inspection & packing only after receiving Q.A. release for packing.

Theoretical Yield (Weight) : 88.84kg-89.38kg ( 99% to 100%)

Actual Yield (Weight) : kg.

Released from Q.C. on :

Signature of Expert staff responsible for manufacturing : (Approved Person)
STEP 11 : PACKING


DISPENSING OF PACKAGING MATERIALS

Dispensing should be done in presence of 2 persons, 1 from Stores & 1 from Packaging Dept.
Dispense the Packaging Material as per the quantities given below.
Overprinting of Cartons / BOX LABELS

Precautions
1. Check that the room & the equipment are cleaned & free from previous product or previous B. No. material.
2. Ensure that the correct set of stereos is issued for overprinting.
3. Record the previous product & batch no. on the BMR.
4. After finishing the overprinting & packing ensure that the remaining stereos are destroyed as per the SOP.
Procedure
1. 1.5 mm Flat rubber stereos will be used for overprinting.
2. The Cartons / Box Labels (for Sale only) will be overprinted for the details in following following format –
M.L.No. __________
B.No. ____________
MFG.DT. __________
EXP.DT. __________
R.P.NOT TO
EXCEED Rs. _______ (For Sale Pack Cartons Only)
L.T.EXTRA
3. The first Carton / Box Label overprinted with above details will be approved by Production & Q.A. for correctness of overprinting.
4. Overprinted Cartons will be stored under lock & key & will be issued for usage by a responsible person.

PRIMARY PACKAGING - Strip Sealing

Precautions
1. Check that the room & the equipment are cleaned & free from previous product or previous B. No. material.
2. Use nose masks & hand-gloves during strip-sealing.
3. Record the previous product & batch no. on the BMR.
4. During strip-sealing ensure that the room temperature is below 250 C & % RH is between 40-50%.
5. Obtain line clearance from Q.A. before strip sealing of tablets.

Procedure
1. Fix the stereo drum with 2 mm rubber stereos containing 2 x 3 sets of following details –
a) M.L.No.
b) B.No.
c) MFG.
d) EXP.
2. For Sale Pack extra 2 x 3 sets of following details should be fixed below above sets.
R.P.N.T.E.
Rs._____ / 4 TABS.L.T.E
3. Ensure that correct change parts of Tablets are fixed (disc/bowl, hopper, chute channel & rollers).
4. Fix the top & bottom foil on the machine rollers.
5. Adjust the temperature of the strip-sealing roller heater to 190 deg C + 20 C.
6. Adjust the cutter for a strip of 4 tablets (2 x 2 type) strip (Sale Pack).
7. Take the impression of the overprinting details of all sets on the bottom side of the foil.
8. Check the details of overprinting & get it approved from Production & Q.A.
9. Start Strip-sealing & Packing after ensuring 0% leakage in the strips.
IN-PROCESS QUALITY CONTROL (IPQC) CHECKS
Following In-Process Quality Control Checks should be carried out during Strip-sealing at a defined frequency.

Parameters
Frequency
1. Room temperature & % RH
Every 30 minutes
2. Leak test
Every 2 hours
3. Sealing Roller temperature
Every 30 minutes
4. Overprinting Details
Every 30 minutes
5. Other observations
Every 30 minutes


Leak Test

Procedure
1. Take representative strips after each 2 hour from the strip-sealing machine such that every pocket (cavity) on the roller is represented in the sample.
2. Fill the dessicator with ¼ th volume of fresh water.
3. Place strips in it and put dessicator plate on them so that strip will not float on water.
4. Apply a vacuum pressure equivalent to 25 mm/ Hg for 1 minute.
5. Cut the strips and check for any leakage.
6. Ensure that there is no leakage.
7. If the leak test is passing, the capsules can be reused in the batch.

In-Process Quality Control chart

Date & Shift :

Time
Room temp.
% RH in room
Roller temp.
Leak Test
Overprinting details
Other observation
Operator & Assistant
Supervisor
Secondary PackAGing

Sample mode – 25 x 50 x 4’s
1. Check that all strips are containing 4 tablets each & are free from any defect.
2. 1 stripis is packed in 1 pre-overprinted carton.
3. 50 cartons are packed in one 3 ply inner corrugated box.
4. The inner corrugated box is pasted with specifically printed box label which is overprinted with Mfg. Lic. No., B. No., Mfg. Dt., Exp. Dt.
5. The inner corrugated box is closed with BOPP tape in C-type having logo on the BOPP tape.
6. 25 such boxes are packed in the following mode (1 x 5) x 5, in one 7 ply outer corrugated box.
7. The outer corrugated box is marked with box marker in specified red colour for Mfg. Lic. No., B. No., Mfg. Dt., Exp. Dt.
8. The outer corrugated box is closed with BOPP tape in H-type having logo on the BOPP tape.
9. The final packing operator stamps the shipper with date & employee no. for traceability.

SAMPLING
Procedure
1. During Packing on the conveyor belt, sampling is done by Q.C. personnel by withdrawing the samples as per following manner –
a) Sale / Export - 10 x 30 capsules for Finished product analysis & 15 x 30 capsules as Control Samples
b) P.S. - 50 x 4 capsules for Finished product analysis & 100 x 4 capsules as Control Samples.
2. The sample should be collected intermittently so that a representative sample of the entire batch is collected.

Transfer to BONDED STORE ROOM
1. The packed goods are transferred to Bonded Store Room on a transfer note (Daily Production Report – DPR) as follows.
RECONCILIATION OF THE ENTIRE BATCH

A) CARTONS
1. Total cartons received from the stores :
2. Rejection during overprinting :
3. Total cartons used for packing :
4. Cartons rejected during packing :
5. Cartons destroyed (2 + 4) :
6. Cartons returned to the stores 1 - (3 + 5) :

B) ALUMINIUM FOIL
1. Total foil received from the stores :
2. Rejection during machine setting :
3. Total foil used for packing :
4. Foil rejected during packing :
5. Foil destroyed (2 + 4) :
6. Foil returned to the stores 1 - (3 + 5) :

C) TABLETS
1. Weight of lubricated blend :
2. Number of tablets :
3. Rejection during compression :
4. Rejection during inspection :
5. No. of tablets transferred to packing :
6. % yield after manufacturing :
7. Total no. of tablets packed :
8. Rejection during packing :
9. Qty. of recovery carried forward :
10. Qty. of rejection destroyed :
11. % yield after packing :

Q.C. ANALYTICAL PROCEDURE


SAMPLING – IN-PROCESS MATERIALS

Procedure
1. After receiving the request note from Production dept., the QC person will be deputed for sampling.
2. The person will open all the containers of lubricated blend whatever may be requested and will draw about 10-20 gm of sample from each drum of the material. The samples will be withdrawn in the following manner.
a) Maize Starch Dried – 30 gm
b) Lubricated Blend – 100 gm
c) Qty. to be sampled for IPQC checks – 100 tablets
3. The composite sample will be analysed as per SOPs & the Production dept. will be intimated for further processing.

SAMPLING – FINISHED PRODUCTS

Procedure
1. During Packing on the conveyor belt, sampling is done by Q.C. personnel by withdrawing the samples as per following manner –
a) Export – 25 x 4 tablets for Finished product analysis & 50 x 4 tablets as Control Samples
2. The sample should be collected intermittently so that a representative sample of the entire batch is collected.
ANALYTICAL PROCEDURE FOR IN-PROCESS MATERIALS


A) MAIZE STARCH DRIED

DESCRIPTION White to off-white powder

BULK DENSITY 0.7 to 0.9 gm/cc

LOSS ON DRYING 4.0%w/w to 7.0%w/w

SIEVE SIZE Should pass through 60 #.


ANALYTICAL PROCEDURE FOR IN-PROCESS MATERIALS


A) MAIZE STARCH DRIED


Description

* Check the appearance of Maize Starch Dried immediately after sampling.

Determination of Bulk Density

a) Procedure

* Weigh accurately 10 gm of Maize Starch Dried in a 50 ml stoppered measuring cylinder.
* Fit the cylinder to the Bulk Density apparatus.
* Run the apparatus for 150 tapping.
* Check the volume occupied by the material.
* Calculate the Bulk Density accordingly.
b) Calculations

WSP
Bulk Density = --------- = gm/cc
VSP

Where,

WSP = Weight of Sample in gm
VSP = Volume occupied by sample after tapping, in ml

Determination of Loss On Drying

Procedure

* Check Loss on Drying at 1050 C for 15 minutes on IR moisture balance.

Checking of Sieve Size

Procedure

* Pass 10 gm of Maize Starch Dried through 60 # test sieve. No particulate should remain above the sieve.
ANALYTICAL PROCEDURE FOR FINISHED PRODUCTS


A) PHYSICAL PARAMETERS

a) Description

* Use around 20 tablets and compare the appearance of the tablets with specifications.

b) Average weight of tablets

* Accurately weigh 20 tablets and find out the mean.

c) Individual Weight Variation

* Accurately weigh 20 individual tablets. Check the weight variation of the tablets. with Average weight of tablets..

d) Average Thickness of tablet

* Check the thickness of minimum 10 tablets by Screw-gauge or Vernier’s Calliper.

e) Average Diameter of tablet

* Check the width of minimum 10 tablets by Screw-gauge or Vernier’s Calliper.

f) Average Hardness of tablet

* Check the hardness of minimum 10 tablets by Hardness tester.
g) Disintegration Time

* Use 6 tablets for the test as per I.P.

h) Leak Tests

* Use 6 strips of the product for the test.

i) Contents of Packaged Dosage Forms

* Use 10 packs of the product for the test as per I.P.
B) DETERMINATION OF ACTIVE INGREDIENTS

1. Paracetamol : Proceed as per Standard Method No xyz
1. Caffein : Proceed as per Standard Method No. xyz
2. Cholpheniramine Maleate : Proceed as per Standard Method No. xyz.
3. Phenylepherine HCL : Proceed as per Standard Method No. XYZ


ESTIMATION OF PARACETAMOL Stated Amount 500 mg / Tablet
(Standard Method No. xyz.)

a) Reagents

1) 10% w/v sodium nitrite
2) 10% w/v Ammonium Sulphamate
3) 10% w/v sodium hydroxide
4) 1:1 HCl. (5N Hydrochloric acid)
* Dilute 5 ml of concentrated Hydrochloric acid with 5 ml distilled water

b) Standard Preparation

* Weigh 125 mg Paracetamol (reference standard) in 200 ml volumetric flask.
* Make volume to 200 ml with distilled water.
* Dilute 10 ml of this solution to 100 ml with distilled water.
* Take 10 ml of solution (62.5 mcg/ml of Paracetamol) for colour development in 50 ml volumetric flask.



) Sample Preparation

* Weigh & crush 20 tablets of
* Weigh crushed powder of tablets equivalent to 125 mg of Paracetamol in a 200 ml
volumetric flask.
* Add around 50 ml of distilled water shake vigorously.
* Keep the solution standing for 15-20 minutes.
* Take 10 ml of above solution to 100 ml with distilled water.
* Take 10 ml of solution (62.5 mcg/ml of Paracetamol) for colour development in 50 ml volumetric flask.

d) Colour development

* To 10 ml of sample / standard solution in 50 ml volumetric flask.
* Add 1 ml of 1:1 HCl
* Add 2 ml of 10% w/v sodium nitrite solution
* Wait for 15 minutes.
* Add 2 ml of 10% w/v Ammonium Sulphamate
* Shake to remove effervescence.
* Add 5 ml of 10% w/v sodium hydroxide solution.
* Dilute to 50 ml with distilled water.
* Measure absorbance at 430 nm using distilled water as blank.

e) Calculations

Asp Wsd 10 10 50 100 200 Psd
-----X ---------X ------- X -----X ----- X -------X --------X ------- X Avg
Asd 200 100 50 10 10 Wsp 100

= mg of Paracetamol / Tablet

Where,
Asp = Absorbance of the sample
Asd = Absorbance of the standard
Wsd = Weight of the standard in mg
Wsp = Weight of the sample in gm
Psd = Purity of the standard
Avg = Average weight of TABLETS
RECOVERY HANDLING

Principles
1. Recovery will be stored separately under controlled conditions of temperature & % RH and will be labelled and accounted properly.
2. Recovery older then one month will not be added to any batch without analysis.
3. Recovery older then three months will be destroyed & accounted for.
4. Maximum 5% recovery can be added to a fresh batch.
5. The shelf life of the fresh batch will be reduced as per the oldest recovery batch added.
6. Recovery of a batch to which recovery is already added should not be carried forward.

Procedure for addition of recovery
1. Inspect the recovery for absence of Aluminium foil and foreign matter.
2. Crush the recovery through multimill using 2 mm screen impact forward medium speed.
3. Sieve the crushed recovery through 20 # sifter sieve to remove the Gelatin flakes.
4. Weigh the sifted material and add it at the lubrication stage.
5. Record all the steps followed during recovery addition.
6. A batch in which recovery more than permitted is added should be subjected to stability studies. i.e. A batch in which recovery added is more than 5%, should be subjected to stability studies.

Also see Pharmaceutical Process Validation
REPROCESSING

Principle
Inspite of the precautions taken during manufacturing, it may happen that a filled batch needs reprocessing due to weight variation, content variation, D.T. variation, etc. In such cases following procedure will be followed.

Procedure
1. Inspect the material for absence of Aluminium foil and foreign matter.
2. Crush the quantity to be reprocessed through multimill using 2 mm screen impact forward medium speed .
3. Sieve the reprocessed material through 20 # sifter sieve to remove the Gelatin flakes.
4. Weigh the sifted material and analyse for required contents .
5. The problem will be discussed in technical committee meeting.
6. Take a small quantity (approx. 1.0 kg) for trial for the desired effect, whatever is decided in the technical committee meeting .
7. After confirming the result of small trial the entire batch can be reprocessed .
8. All the steps taken for reprocessing, will be documented and the reprocessed batch will be subjected for stability studies .

STABILITY STUDIES   also see Drug Product Forced Degradation

Procedure
1. Routine stability studies should be carried out in the same pack as it is marketed at normal storage conditions to ensure the shelf life.
2. Sufficient sample should be drawn for stability studies after 1, 2, 3, 6, 12, 18, 24, 30 & 36 months.
3. In case of any major change in the formulation or packaging, accelerated stability studies should be carried out at 400 C temperature & 75% RH for 1, 2, 3 months in the same pack as it is marketed.
4. Stability studies should be repeated in the following cases
a) Change of batch size,
b) Change of machinery,
c) Batch containing more recovery than permitted in MFC,
d) Change in formulation or process,
e) Change in the Primary Packaging material,
f) Change in the vendor of major ingredient,
g) If the entire batch is reprocessed.
This format will give you exact idia about , how to write Master Manufacturing Formla for a WHO GMP pharmaceutical unit.
Following are some of articles which;will be useful for you in further understanding of aspects of sterile dosage form manufacturing

Pharmaceutical Validation

Clean Room Classification

Pharmaceutical Industry

Pharmaceutical Manufacturing

Clinical Trials

FDA guidelines

What is 21 CFR PART 11 compliance

What is HEPA filter

To Find Pharmaceutical jobs and make a Pharmaceutical careers see here pharmaceutical companies

2 comments:

bhaskar reddy said...

if leak test pass how you use the tablets /capsule for the batch ,we are usiging a color solution used for leak test ,it will not effect the batch quality, is it acceptable for fda.

Martin said...

WE HAVE TO DISCARD ALL THE TABLETS WHICH ARE USED FOR ANY TESTING INCLUDING LEAK TESTS , THEY CAN NOT BE USED

Posted by: Martin

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