Manufacturing operations and controls are important to ensure the identity, strength, safety, and purity of pharmaceutical products. Key aspects include sanitizing manufacturing premises, preventing mix-ups and cross contamination, processing intermediates and bulk products while maintaining quality, conducting packaging operations with controls, in-process quality control testing during manufacturing and packaging, and only releasing finished products that meet all requirements after quality approval. Maintaining proper documentation and investigating any deviations or unusual events are also important parts of manufacturing and quality control.

1. MANUFACTURING OPERATIONS
AND CONTROLS
5/21/201
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PRESENTED BY:
Mr. Ankush P. Jadhav & Miss. Tejashree R. Kedar
M. Pharm (PQA)
Email id: jadhavbrand@gmail.com
………..tejashrikedar@gmail.com
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2.  INTRODUCTION
 SANITATION AND MANUFACTURING PREMISES
 MIX – UP AND CROSS CONTAMINATION
 SOUCES OF CONTAMINATIO AND MIX- UP
 PROCCESSING OF INTERMIDIATE AND BULK
PRODUCT
 PACKAGING OPERATIONS
 IPQC IN MANUFACTURING AND PACKAGING
 RELEASE OF FINISHED PRODUCT
CONTENTS
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3. SIGNIFICANCE
MANUFACTURING :TO produce goods and service of
quality accepted by customers in desired quantities
according to time schedules and at minimum cost.
CONTROL: Producing right kind of goods and services that
satisfy customers need.
Minimizing cost of producing goods or services
Manufacturing operation and controls are as follows :
1.Identity-Refers to correct identification of
product,people,materials,machines,equipment & locations
where mfg.activities are carried out.
2.Strength-refers to concentration of active substance in
desired quantity in each unit of the finished pharmaceutical
product.
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INTRODUCTION

4. 3.Safety-Person who is going to consume the
product. Safety of people should be also
considered. Mfg.operations should be safe
while products are being mfg.
4.Purity-Feedom from cross contamination
and staff (Expert technical staff) approved
by FDA. They from mix-ups.
Operation done-Qualified technical should be
trained, have appropriate
knowledge,skill,attitude to carry out their
responsibilities.
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5. SANITATION OF MFG.PREMISES
 Mfg.areas –state of cleanliness & sanitary conditions.
 Must use validated cleaning &sanitising procedures.
 Identify Certain locations-collection of
dust,debris,waste/trash material.
 Containers of suitable size & shape made from plastic or
recycled plastic bags can be put into containers & trash
collected.
 At regular intervals-twice in shift-deposited at backside of
plant in room away from processing area-central waste
material sit/ scrapyard.
 .
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6.  Define the detergent, its concentration, frequency of
cleaning, persons responsible for doing & supervising job.
 Record of activities should be made, with date and time of
cleaning, person who performed and supervised job.
 After cleaning activity area should be disinfected by using
suitable method, using proper concentration-records-
appropriate people-regular time-supervised by
housekeeping supervisor-SOP.
 Documents required-1.SOP- on
housekeeping,covering,cleaning & disinfection of various
areas.
 2.Reports of cleaning & disinfection activities.
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7. MIX-UPS & CROSS CONTAMINATION
 Big danger & precaution should be taken to avoid the
same.
 Mix-up-undesired material into desired material, visibly
seen e.g.- cartons of one product into another, tablets of
one product with another product which has different size,
shape or color etc.
 Contamination-some material where it is not desired, not
visible e.g.- fine dust of one product into another product,
fine black particles into processing materials
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8. SOURCES OF CONTAMINATION AND MIX-
UPS
 Materials
 People
 Machine and operations
 Areas etc.
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9.  Materials
 Improper handling of material lead to
spillage on ground & cause contamination
 Broken containers
 Dusty uncontrolled activities
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10.  People
 Indisciplined activities
 Infectious nature of skin/body parts
 Trained people
 By keeping movements restricted
 Using hand gloves
 Mask
 Proper uniform
 Medically strictly examined
 Infectious disease/open wound treated by
qualified doctor.
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11.  Machine and operations
 Must be clean
 Covered when not in use
 Should be checked before use to avoid
contamination
 E.g.-Discharge of exhausted
dust,smoke,fumes,gases should be
monitored.
 Sensitive material-Beta lactam antibiotics
,toxic drugs
 SOPs ,records should be kept
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12.  Mfg Areas-Aseptic filling area
 Other sterile area
 Non-sterile processing area
 Corridors, cleaning rooms, outside areas of
the plant
 SOPs
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13. CONTROLLING OF CONTAMINATION &
MIX-UPS
 Exhaust system -proper air filtration & dust collection
 Separate air handling unit for each work station-avoid
particulate contamination
 Different rooms at different air pressure
 Packaging lines should be separate at 1.2 to 1.5 meters-
avoid mix-ups
 SOPS-PACKAGING LINE
 Similar looking products-packed/processed.
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14. D. Trained people
G. Technical/Organizational Measures
Production in segregated area
Providing appropriate airlocks, pressure
differentials, air extraction
Minimizing risk of contamination by
recirculation/reentry of untreated
Wearing protective clothing
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15. PROCESSING OF INTERMEDIATE & BULK
PRODUCT
 Starting from the receipt of raw materials-to ready for
packaging into their primary-finished packs-points to kept
in mind that identity,strength,safety & purity of the
product should be maintained—
1.Before stating process, the material received from the
stores should be checked for the identity & quantity-
done by labels on containers & by weighing or measuring
quantity of materials.
2.Process area & equipment must be clean & no traces of
previous product.
3.Environmental conditions must be with processing
requirement for e.g.temp.relative humidity, pressure etc.
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16. 4.Containers for filling of finished products should be clean to
acceptable level of cleanliness. Bulk containers –storage of
in-process materials also be cleaned.
5.Yield of materials at all critical stages of operations like
granulation,compression,filling operations of capsules,
liquid bottles etc.and compared with T.Y .expected, any
abnormal deviations must be investigated & corrective
action taken.
6.Check pipelines and other pieces of equipment used for
transportation of products from one area to another area
corrected in a correct manner. Such thing should thoroughly
cleaned/sanitised to get desired level of limits of microbial
presence.
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17. PACKAGING OPERATIONS
 As for mfg.operations ,packaging operations also follow
precautions to get a good quality product at end.
Following points should be considered.
1.Avoid risk of contamination and mix-ups
2.All packaging equipment & lines must be cleaned before
staring a fresh packaging activity. Line clearance—record
maintained.
3.Each packaging equipment and line identified by fixed
board indicating following information-Name of product,
batch no., Pack size, date of packing.
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18. 4.Normally filling & sealing should be followed by labelling
and final packing. If labelling is delayed appropriate steps
should be taken to prevent mix-ups.To avoid this no batch
should be taken for packing unless all the packing
materials are available in full quantities.
-Bulk tablets(for want of foils)
-Strips or blisters(for want of cartons)
-Filled cartons(for want of shippers) such situation must be
avoided.
5.Over printing on labels,cartons,coated tablets etc.should be
carefully planned
6.On line verification of all labels by automated electronic
beam helpful in preventing mix-ups
7.Empty packet detection in tab/cap. should be used.
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19. 9.Online packaging checks should be carried out for
following-
a.Genreal appearance of the package
b.Completeness of package
c.Correctness of pack & packaging materials
d.Correctness of over printed details
e. Correct version of printed packaging material is used.
f.Weight check of carton & shipper may be useful.
10.Products which are involved in an unusual event during
packaging operations should be fully investigated-record
made-packed after approval of authorized person-
additional Q.A.dept.
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20. 11.Any significant or unusual discrepancy observed then it
should be investigated & satisfactorily accounted before
release.
12.After completion any unused batch coded packaging
materials should be destroyed and the destruction
recorded.
Documents Required
1.BPCR
2.SOP & record of IPQC
3.Deviation records if any
4.Incident reports if any
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21. IPQC IN Mfg & Packaging
A For Mfg.Operations-
b.Assay,moisture,angle of repose at end of granulation
c.Physical parameters of compression of tablets
-Weight
-Thickness
-Hardness
-Friability
-Disintegration test
-Dissolution test
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22. d. Fill weight/vol. in amp./liq. Orals etc.
e. pH of solution before filling
f. Bulk volumes of liquids etc.
g. Environmental conditions verification
e.g.temp. etc.
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23. b.For Packaging Operations-
a. Packaging operations/lines continually
monitored to sure the integrity of finished
products not compromised.SOP & check
list should regularly signed by trained
people.
b. Automated controls & monitors should be
checked regularly during production
c. Online control of the product-
1.General appearance of the package &
physical defects if any
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24. 2.Fill weights,volumes,unit quantities etc.
3.Completeness of package-all components
of the pack without fail
4. Correctness of all materials used.
5. Correctness of over printed details
6.Correct functioning of all on line monitors.
7.Environmental conditions records- temp.,
humidity etc
8.Collecton of samples for testing & retention
should be recorded. Tested/Inspected
samples should not be returned back
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25. RELEASE OF FINISHED PRODUCTS
 Last activity
 Move into commerce freely
 Done with great care
1.Finished products must be placed in quarantine
2.Samples of product taken at intervals during packaging
process retained for examination by quality control
laboratory
3.Doccumentation should be reconciled, completed/sent for
a complete documentation audit
4.All parameters are satisfied along with Q.C. release the
product from its quarantine status
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26. 5.Finished product should be released for
sale from Q.A .dept
Documents required-
Batch release SOP & reports
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27. REFERENCE
• Manohar A. Potdar “Pharmaceutical Quality Assurance” Nirali Publications, 6th
edition, 2017.
• Sawant R., Hapse S., “Fundamentals of Quality Assurance Techniques” 2nd
edition, Career Publications, May 2016.
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