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Wednesday, May 12, 2010

Standard Operating Procedure Title: Procedure for Line clearance

1.0 PURPOSE:

1.1 It is established to assure quality of Product and to minimize the chances of error.

2.0 SCOPE:

2.1 It is applicable to Quality Assurance Department.


3.0 RESPONSIBILITIES AND AUTHORITIES:

3.1 Manager Quality Assurances.
3.2 Assistant Manager Quality Assurance.
3.3 Quality Assurance Officer.

4.0 PROCEDURE:

4.1 GENERAL POINTS:


a. After receiving intimation for line clearance from Production, Q.A Officer
visit the concerned department.
b. Check that work station is clean of previous product and spillage on the line
area is suitably mopped and cleaned and in case of injectable it is mopped
with Dettol phenol solution and properly fumigated with formalin and
KMnO4.
c. See name of product ,batch no, batch size, manufacturing and expiry date.
d. Check that all relevant documents are complete in file.
e. Check status of product i.e. commercial, sample or supply.
f. Issue line clearance after confirmation that all the requirements of check list
of the relative process have been fulfilled.
.


4.2 AT GRANULATION.

 Check the granulation area with respect to its cleanliness and other required equipments including mixer, oscillator, granulator,fludized bed dryer, etc.
 Check that humidity/temperature of area(if necessary) is suitable for process.
 Check that all the ingredients are present and identified properly with reference to product specification.
 Assure that the approved SOPs and the Work instructions are being followed.
 Issue line clearance certificate and check list after confirmation that all the requirements of check list for granulation have been fulfilled.



4.3 AT MANUFACTURING ( LIQUIDS)

 Check that clean protective clothing ,gloves and masks are being used.
 Check the cleanliness and identification of manufacturing tools including manufacturing storage/filling tanks, mixer and other containers.
 Check that manufacturing is being carried out against approved raw material requisition and approved manufacturing instructions are being followed.

 Check that all the ingredients are properly identified with product name, batch no, material name and quantity.
 Assure that Water for injection is approved from Q.C before starting manufacturing process (in case of injection).
 Assure the addition of active ingredients and other excipient under controlled humidity and temperature.
 Issue line clearance certificate and check list after confirmation that all requirements of check list have been fulfilled.


4.4 AT COMPRESSION

 Make sure that dissolution/disintegration time what ever the specification is and friability have been checked and result are within range.
 Check physical appearance of granules/ powder and tablets.
 Check that humidity is under control if necessary.
 Check the weight adjustments of machine by weighing the tablets as given by Q.C.
 Check sticking, capping and all other in process physical problems.
 Check hardness / thickness of tablets, limits of hardness/thickness should be within range of product specification.
 Check weight variation sheet and enter weight and hardness in it.
 Products which are not compatible can not be compressed in same compression area.
 Issue line clearance certificate and line clearance check list after confirmation that all the requirements have been fulfilled.
 Check the compliance of line clearance at regular intervals of time.

4.5 AT COATING

 Check cleanliness of coating pan,containers,siliverson mixer exhaust duct, hot air supply and compressed air filter etc.
 Assure that approved SOP and Work instructions are being followed.
 Check the ingredients of coating solution.
 Issue line clearance certificate and check list after assuring that all requirements of coating check list have been fulfilled.

4.6 A T FILLING

 Check cleanliness and washing of filling machine and filling containers(bottles,vials,ampoules etc ).
 Check volume/weight what ever is the case filled by machine as given by Q.C,Weight 6 sachets in case of powder, Make pool volume of 5 ampoules in case of injectable , weigh 20 capsules in case of encapsulation.
 Check bubble test before ampoule filling the injectable in area for integrity of filter.
 Assure sterilization of vials and ampoules at 240 degree centigrade for 2 hours and rubber stoppers at 100 degree centigrade.
 Issue line clearance certificate and check list after confirmation that all the requirements of the check list have been fulfilled.
 Check the compliance of line clearance at regular intervals of time.


4.7 AT BLISTER
 Check that machine is set according to product batch no,mfg.and exp.date.
 Check that product expiry should comply with product specification.
 Check coding on blisters and sign the blisters.
 Check physical appearance of tablets/capsules,PVC,PVDC,and Al:foil.
 Issue line clearance certificate and line clearance checklist after confirmation that all the requirements of checklist have been fulfilled.
 Check compliance of line clearance at regular intervals of time.



4.6 AT PACKAGING

 Check all the packaging material identities of the product according to product specification.
 Check that all the relevant record is complete.
 Check that all the materials are released for packaging from Q.C.
 Check the batch no, manufacturing and expiry date of product to be packaged and that printed on packaging material.
 Confirm the price in case of commercial packaging.
 Issue line clearance certificate and check list for packaging after confirmation that all the requirements of packaging check list have been fulfilled.
 Check the compliance of line clearance at regular intervals of time.









5.0 RECORD REQUIRED:
The following record shall be generated in accordance PROCEDURE FOR LINE CLEARANCE.:

Required record Form reference number
Line clearance slip QF/037/01
Check list for granulation QF/108/01
Check list for compression QF/185/01
Check list for coating QF/186/01
Check list for blistering QF/O74/01
Check list for liquid manufacturing QA/204/01
Check list for encapsulation QF/075/01
Check list for packaging QF/O33/01
Check list for filling QF/109/O1
Check list for injectable QF/049/01

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