Packaging And Labeling control

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Packaging And Labeling control

• Prepared by Paras Shah
• Guided by Dhaval Rathod

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• Packaging
• Packaging is prepared for goods
  transportation ,distribution , storage, retailing
  and use.
• Level of packaging
• Primary packaging
• The Primary packaging is the first
  level of containment that is directly contact
  with the finished drug product.
• This could be
• A blister card or pouch for tablets or capsules.
• A glass or plastic bottle for tablets, capsules
  , powder,
• or liquids.
• A glass or plastic syringe , ampoules or vials
  for injectable drug product.
• An aluminum or laminate tube for cream and
  ointment.
• Secondary packaging.
• Tertiary packaging .

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• Material examination and usage criteria
• There shall be a written procedure describing in
  sufficient in detail of receipt, identification,
  storage, handling, sampling ,and testing of
  labeling and packaging materials, such written
  procedure shall be followed. labeling and
  packaging material shall be sampled and tested
  before use.
• Any labeling and packaging materials meeting
  appropriate written specification may be approved
  and release for use.
• Record shall be maintained for each shipment
  received of each different labeling and packaging
  material indicating receipt, examination and
  whether accepted or rejected.
• Labels and other labeling material for each
  different drug product, strength, dosage form
  shall be stored separately with suitable
  identification.

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• e. Obsolete and out dated labels , labeling and
  other packaging material shall be destroyed.
• f. Use of gang printed labeling of different
  drug products or different strength of the same
  drug product is prohibited unless the labeling
  from gang printed sheet is adequately
  differentiate by size ,shape or color.
• g. If cut labeling used, labeling and packaging
  operation shall include special control procedure

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• Labeling issuance
• labeling materials issued for a batch shall be
  carefully examined for identity and conformation
  to the labeling specified in the master or batch
  production records.
• Procedure shall be written describing in
  sufficient detail, the control procedure employed
  for the issuance of labeling .
• procedure shall be used to reconcile the
  quantities of labeling issued, used ,return and
  shall require evaluation of discrepancies found
  between the quantity of drug finished product and
  the quantity of labeling issued when such
  discrepancies are out side narrow preset limit
  based on historical operating data.
• All excess labeling bearing lot or control
  numbers shall be destroyed.
• Returned labeling shall be maintained and stored
  in a manner to prevent mix up and provide proper
  identification.

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• Packaging and labeling operation
• There shall be a written procedures design to
  assure that correct labels labeling and packaging
  materials are used for drug product, such written
  procedure are
• Prevention of mix ups and cross contamination by
  physical or spatial separation from operation on
  other drug product
• Filled drug product container that set a side and
  held in unlabled condition for future labling
  operation

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• Identification of drug product with a lot or
  control number that permit the determination of
  history of manufacture and control of batch.
• Examination and packaging and labeling material
  for suitability and correctness before packaging
  operation.
• Inspection of packaging and labeling facilities
  immidiately before used assure that all the drug
  products have been remove from previous
  operation.

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• Control of packaging material
• packaging operation should be conducted in
  suitable buildings, facilities and condition.
• The facility should provide appropriate
  environment protection ,segregation and
  containment for the products being packaged, so
  as to eliminate the risk of cross contamination,
  mix ups or substitution.
• There should be a master batch packaging record
  for each product to be packaged and packaging
  batch specific copies made from these.
• All commercial finished products should bear a
  batch number and an expiry date on both primary
  container lbles and cartons.

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• Handling of printed packaging material
• Printed packaging material should be stored and
  transported in closed containers identified by
  name, code number and control number.
• Printed packaging material should be stored in
  secure area.
• To minimize the mix- ups, bar coded roll labels
  should be used whenever possible and the bar
  codes should be read on line just prior to
  adherence to the primary container.
• Over printing of labels and cartons with batch
  number and expiry should preferably be performed
  on line.
• Specimens of all printed component used should be
  added to the batch packaging record.

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• Excess overprinted packaging materials should be
  destroyed as soon as possible.
• Excess packaging material not overprinted may be
  return to stores only if identified by code
  number and control number . The return should be
  recorded.
• All printed packaging material must be accounted
  for at receipt and during usage.

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• The master batch packaging formula
• It will contain the following data field
• Drug product name, identification number and
  strength.
• Names ,identification number and quantities of
  each packaging component
• Primary container bottle, closures and liner,
  foil, laminates etc.
• Label
• Carton
• Tamper evident feature
• Child resistant feature
• Shipper, divider ,other protective packaging
• Complete description of the equipment to be
  utilized for the packaging operation.

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• Characteristics to be monitored during filling
  and packaging.
• Sample requirement and frequency.
• For the specific batch being packaged
• Batch number of the drug product
• Packaging lot or control number assigned
• Quantities of packs expected and action level
  value
• Quantities of each packaging component issued.
• Expiry date to be assigned

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• The potential for mix up and cross contamination
  may be further reduced by physical segregation
• A physical barrier between adjacent lines.
• Adequate space and physical segregation to
  assemble bulk product and packaging component.
• adequate space for assembly of finished packaged
  stock prior to transfer to the warehouse.
• Dust extraction bulk table hoppers.
• Cover over open hoppers . Open empty container
  and filled but uncapped container.
• Delay start up until all packaging material are
  available.

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• Labeling control
• For new or changed labeling there must be in
  place a procedure that clearly defines
• Who is to review and approve the copy.
• What each function is to check and approve
• Material management
• Production
• Marketing
• Medical
• legal and regulatory affair
• Technical service and quality control
• Editorial
• System manager

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• c. The reviewer and approvers should preferably
  be defined by name.
• d. The feedback loops that confirms that the
  changes has actually been introduced.
• e. A unique numbering system that has clearly
  distinguishes between labeling for different
  product and strength and also between different
  version of the same labeling.

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• Tamper resistant packaging requirement for OTC
  drug
• It was consider that prescription products are
  maintained under the control of the pharmacist
  and consequently are less vulnerable to
  tempering.
• Effectiveness criteria were established instead
  of some guidance
• film wrapper
• blister or strip packs
• bubble packs
• heat shrink bands
• foil, paper or plastic pouches
• bottle mouth inner seals

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• Drug product inspection
• Packaged and labeled product shall be examined
  during finishing operation to provide assurance
  that containers and packages in the lot have the
  correct label.
• On line inspection
• Critical defect
• Major defect
• Minor defect

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• Line clearance
• the procedure have been established to prevent
  mix-ups of products, containers, components and
  mistakes in documents
• Mix-ups and mistakes can occurs when procedures
  and GMP are not followed.
• Particular care should be taken
• When starting a new operation
• At change of shift
• When additional components are needed

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• line opening
• It is performed to ensure correct product
  ,component and documentation for comment cent
  of the process operation.
• line cleaning
• It is performed to remove and clean from
  the line all products, components and department
  manufacturing document

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• Reconciliation
• A process to measure efficiency of use for raw
  material or components.
• on completion of the procedure all the partial
  box of leaf lets must be counted. And all the
  partial box shall be sealed before return to
  warehousing.
• Possible cause of unsatisfactory reconciliation
• Mixed or rough label
• Error in initial counts of labels or cartons
• Error in final packed count
• Incompletely count samples, rejects and returns
• Wrong number of labels or bottles
• Lost of labels or cartons or leaflet

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Expiration dating

• To assure that the drug product meets applicable
  standard of indentity strenth, quality, and
  purity at the time of use. It shall bear and
  expiration date determine by stability testing
• Expiration date shall be related to any storage
  condition stated on labeling.
• If the drug product is to be reconstituted at the
  time of dispencing , its labling shall bear
  expiration information for both reconstituted and
  unreconstituted drug product.
• Homeopathic drug product shall be exempted from
  the requirement of the section.

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Thank you