Prepared by: Paras Shah Guided by: Dhaval Rathod

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 o A blister card or pouch for tablets or capsules.o A glass or plastic bottle for tablets, capsules , powder, or liquids.o A glass or plastic syringe , ampoules or vials for injectable

drug product.o An aluminum or laminate tube for cream and ointment. Secondary packaging. Tertiary packaging .

Material examination and usage criteria:

a. 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.

b. Any labeling and packaging materials meeting appropriate written specification may be approved and release for use.

c. Record shall be maintained for each shipment received of each different labeling and packaging material indicating receipt, examination and whether accepted or rejected.

d. Labels and other labeling material for each different drug product, strength, dosage form shall be stored separately with suitable identification.

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

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.

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

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.

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.

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.

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.

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.a. Labelb. Cartonc. Tamper evident featured. Child resistant featuree. Shipper, divider ,other protective packaging Complete description of the equipment to be utilized for the

packaging operation.

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

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.

Labeling control: For new or changed labeling there

must be in place a procedure that clearly defines:

a. Who is to review and approve the copy.b. 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

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.

Tamper resistant packaging requirement for OTC drug:

a. It was consider that prescription products are maintained under the control of the pharmacist and consequently are less vulnerable to tempering.

b. 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

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

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

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

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

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.