Manufacturing operations and control must ensure identity, strength, safety, and purity of products. Facilities must be properly sanitized and cleaned to prevent contamination and mix-ups. During packaging, lines must be cleared properly and monitoring must ensure integrity of finished products. In-process and finished product testing must meet specifications before final product release. Strict controls over materials, personnel, equipment, and facilities help guarantee quality and prevent issues like cross contamination.

1. Manufacturing Operation & control
1
PRESENTED BY
RAJESH LAXMAN RAUT
M.Pharm I (QA)
School of Pharmacy SRTMU Nanded

2. O Introduction
O Sanitisation of Manufacturing Premises
O Mix-up & cross contamination
O Packaging Operation
O IPQC in Manufacturing & Packaging
O Release of Finished Products

3. 4 key words should always be kept in
mind during the manufacturing
operations
Identity
Strength
Safety
Purity

4. Production area should be maintained in state of
cleanliness and require sanitary conditions
One must use validated cleaning and sanitising Procedure
Recycled plastic bag are used in Plastic or Stainless Steel
into which trash and waste material are disposed
Records of Sanitation are maintained properly

5. a) Introduction
b) Source of Contamination and mix-ups
c) Controlling of Contamination and
Mix-ups
a) Trained People
b) Technical or Organisational Measures

6. It posses big danger and hence necessary Precaution
measure should be taken to avoid the same
Mix-ups can be defined as presence of undesired materials
into desired material which can generally be visibly seen.
Eg: Carton of one product into another
Tablet of one product with another product which have
different size, shape or colour etc
Contamination is also presence of some material where it
is not desired
Eg: Fine dust of one product into another

7. a)Material
b)People
c)Machines And Operations
d)Areas

8. a) Exhaust System with proper air filter
b) Separate air handling unit
c) Different Rooms(nature of Product)
d) Well Segregated Central Packaging area in
packaging lines
e) SOP maintained for Packaging line clearance
f) Similar looking product should be avoided to
be processed or packed in vicinity of each
other

9. In Pharma Processing the People
should be trained in their jobs also in
Principle of cGMP
Following the correct and disciplined
procedure and GMP help in avoiding
cross contamination

10. a)Production in Segregated Area
b)Providing Appropriate Airlocks
c)Using cleanliness of status of Equipment
d)Testing of residues on equipment and
areas
e)Wearing protective clothes
f)Using closed system for material handling
g) Cleaning of equipment

11. a)Yield of material at critical stages of
operations should be checked
b)Formulated product yield checked &
compare with theoretical yield any
abnormal deviation must be investigated
c)All IPQC checked should be carried out
d)Effect of environmental condition on
intermediate products

12. Clean packaging lines and equipments for
fresh packaging
Line clearance SOP should be followed and
records are maintained
Selection of Packaging material
Check whether properly packed/not

13. For manufacturing Operations:
Assay moisture content angle of repose
Bulk density of granulating material
Physical parameter for compression of tablet
O Weight O Thickness O Hardness
O Friability O Disintegration O Dissolution
Fill weight/volume in amp/vials/liquid orals
pH of solution before filling
Bulk volume of liquid oral

14. For packaging Operation:
a)Packaging line should be
continually monitor ensure the
integrity of the finished product
b)Automated controls &monitors
should checked regularly
c)Online control of Product
O general Appearance O correctness of all material
O Filled wt volume unit quantities
O correctness over printed details

15. O Released in lot only by authorised
person
O Documents should be reconciled
completed
O When all required parameter are
satisfied including the document audit
QC may recommended release of the
Product from its quarantine Status

16. 1. Pharmaceutical Quality assurance
by M. Potdar