Anda di halaman 1dari 19

Y Y

Y
 
Y 

@ "Y " is part of a quality system covering the


manufacture and testing of active pharmaceutical
ingredients, pharmaceutical products, and medical
devices. GMPs are guidelines that outline the aspects
of production and testing that can impact the quality
of a product.
a a
@ mnce the finished dosage form is made, this department
puts it into primary container and lables it.Packaging
represents a critical manufacturing operation requiring
strong GoodManufacturing Practices (GMPs).

@ The final stage of manufacturing process is packaging,two


types of packaging that is primary and secondary
packaging, labelling.

@ The process of packaging of medicinal products is


involving the risk factors that may affect the quality of the
finished medicinal products and may also cause mix-ups.
@ The increased number of the defects of medicinal products
occurred due to deficiencies in the process of labelling and
packaging.

@ Because of the many products and packaging materials,


personnel in this area must be alert to prevent mix-ups.

@ Controls and in-process checks are carried out throughout


the packaging/labeling operation to ensure proper labeling.

@ GMP m PACKAGING mPERATImNS concerning with


packaging of medicinal products and prevention of mix-
up.
@ Before going to the packaging operations, particular
attention should be given to minimising the risk of
cross-contamination, mix-ups.

@ Different products should not be packaged in close


proximity unless there is physical segregation.

@ Before packaging operations are begun, steps should


be taken to ensure that the work area, packaging
lines, printing machines and other equipment are
clean and free from any products, materials
previously used. The line-clearance should be
performed according to an appropriate check-list.
Y Y 
 
@ purchasing from approved suppliers;

@ primary packaging materials for sterile products (vials, rubber


stoppers, syringes, etc.) and of printed materials;

@ Printed packaging materials should be stored and transported in


closed containers.

@ These materials should be stored in secure areas.

@ That should be apprived by Q.C

@ To minimise risk of mix-ups coded lables should be used.just prior


to adherence to the container should be read once.
  
@ Packaging operations should be conducted in suitable
buildings,facilities and conditions.

@ Incase of sterile products throughout the process


aseptic conditions should be maintained.

@ The facilities should provide approprite environmental


protection for the products being packaged,so as to
eliminate the risk of mix-ups and cross contamination.

@ All products should bear a batch no and expiry date¶.


a
 
Receipt:
There should be written procedures and records for the
receipt of each delivery of each primary and printed
packaging material.
The records of the receipts should include:
a) the name of the material on the delivery note and the
containers;
b) the "in-house" name and/or code of material.
c) date of receipt;
d) supplier's name and, if possible, manufacturer's name;
e) manufacturer's batch or reference number;
f) total quantity, and number of containers received;
g) the batch number assigned after receipt;
` Y Y
 a

@ A Batch Packaging Record should be kept for each batch.It should be


Packaging Instructions, the method of preparation of such records
should be designed to avoid transcription errors.

@ The record should carry the batch number and the quantity of bulk
product to be packed.

@ Before any packaging operation begins, there should be recorded


checks that the equipment and work station are clear of previous
products,documents or materials not required for the planned packaging
operations, and that equipment is clean and suitable for use.
@ The following information should be entered at the time each
action is taken and, after completion, the record should be
dated and signed in agreement by the person(s) responsible for
the packaging operations:
a) the name of the product;
b) the date(s) and times of the packaging operations;
c) the name of the responsible person carrying out the
packaging operation;
d) the initials of the operators of the different
significant steps;
e) records of checks for identity and conformity with
the Packaging Instructions including the results of in-
process controls;
f) details of the packaging operations carried out
including about equipment and the packaging lines used;

g) whenever possible, samples of printed packaging materials


used,including specimens of the batch coding, expiry dating
and any additional overprinting;

h) Records of any deviations from the operation.


Ya


@   

   

  
 
 
   
 
 
 
   

@ 
 
   
 

 


  
 


@  
    
   
 


 


@ 
 

    
    


   
       


  
  


@ 
  
    


 


 

 
    



 

 
@ All packaging equipment and systems should be operated and
used in accordance with the manufacturer's or other established
instructions

@ There should be valid justification and authorization by the


supervisor for any deviation from those instructions on the
part of the operator.

@ Current federal and state label requirements, whichever is


more stringent, must be adhered to The desired components are
as follows:
1. Proprietary and non-proprietary name
2. Dosage form
3. Strength
4. Strength of dose and total contents delivered
5. Beyond-use date
6. Control number (lot number)
The packaging operator should verify that:

1.The packaging system (drug, materials, and machines) is in


correct working order

2. All procedures have been performed properly.

3. Control records of all packaging operations must be kept


per state and federal guidelines, and include the following
information:
1. Complete descriptions of the drug, e.g. name,
strength, dosage form
2. The name of the product's manufacturer.
3. Manufacturer's control number (lot number)
4. Expiration date of the manufacturer's original container
and the beyond use dating of the packaged product.

5. Number of units packaged, total contents delivered per


unit, and the date(s) they were packaged.

6. Initials of the operator and the pharmacist responsible


for packing of each individual run.

7. Description of the packaging materials and equipment


used.
@ xpon completion of packaging, all unused drug stock
and finished packages should be removed from the
packaging area.

@ xnused lables must be removed from that area.

@ The packaging machinery and related equipment


should then be completely emptied, cleaned, and
inspected before commencing the next packaging
operation.

@ All packaged drugs should be stored in a temperature


and humidity-controlled environment.
@ packaging materials should be stored and used in
accordance with the manufacturer's instructions and
any applicable state or federal regulations.

@ Daily records of temperature and humidity shall be


maintained.

@ Written procedures governing packaging operations


should be developed.

@ mperators must be trained and must demonstrate


about equipment operation and packaging
procedures.





@ http://pharmapedia.wikidot.com/gmp-documentation
@ http://www.ascp.com/advocacy/briefing/upload/Guid
elines%20on%20Prepackaging.pdf
@ http://www.picscheme.org
@ http://www.cgmp.com/packaging.htm
@ http://en.wikipedia.org/wiki/Good_manufacturing_pr
actice