1.0 Purpose
1.1 To lay down the procedure for the line clearance of the area / equipment of manufacturing operations carried out before the start of operation / stage during the manufacturing / packing to avoid any contamination or mix-ups of the previous product to the next product in manufacturing area.
2.0 Scope
2.1 This SOP is applicable to all stages of manufacturing operations carried out before the start of operation / stage during the manufacturing / packing at “NAME” Pharmaceuticals Ltd.
3.0 Responsibility
3.1 Sr. / Officer, Production
3.2 Sr. / Officer, Quality Assurance
4.0 Abbreviations and Definitions
4.1 Contamination: Contamination is the presence of any foreign substance in our products. It may be: Physical: hair, foreign objects, dirt, dust, pollens.
Chemical: cleaning agents, lubricants, other products.
Microbiological: bacteria, molds, spores, yeasts.
4.2 Cross contamination: Contamination of a starting material or intermediates or finished products by another material or product during the production is called cross contamination.
4.3 Mix-ups: Mix up is the contamination of one product with another product by human errors or inadequate process or plant design.
4.4 Line Clearance: Procedure for ensuring that no left-over residues of previous product have been remained and it shall be carried forward to the next product.
4.5 QA : Quality Assurance
4.6 HMI :
Human
Machine Interface
4.7 BMR : Batch Manufacturing Record
4.8 BPR : Batch Packing
Record
4.9 SOP : Standard Operating Procedure
4.10 Dept. : Department
5.0 Materials and Equipment
5.1 None
6.0 Precaution / Health and Safety Considerations
6.1 None
7.0 Procedure
7.1 The Production Supervisor/ Personal shall ensure that the necessary precautions are taken for line cleaning before obtaining line clearance from QA Dept.
7.2 As soon as packing of a batch is over, remove all the cartons, labels, bottles, strips, outers, any material left over on the line and on the lower space of the belts joints.
7.3 Check that all the remaining material like capsules, tablets, strips, bottle, etc. are removed out from packing operation area for reworking/rejects.
7.4 Remove the label of the hopper and replace with a new one for the batch to be started and ensure that the hopper is cleaned properly.
7.5 Remove any other packing material from packing area.
7.6 Ensure that Stereo of previous product is submitted to production officer / kept in dedicated place.
7.7 Put an authorized overprinted specimen of strip / blister / cartons / label in a folder for ready reference.
7.8 Change the status of batch details.
7.9 The Production person should ensure that line is cleaned as per SOP and all process documents and remaining materials from the previous process are removed before inviting QA for line clearance.
7.10 After receiving intimation for line clearance from Production, QA person shall visit the concerned department.
7.11 QA Person shall check following points (but not limited to):
7.11.1 Check that work area is clean of previous product and spillage on the line area is suitably mopped and cleaned.
7.11.2 Check the name of product, batch no, and batch size, manufacturing and expiry date.
7.11.3 Check that all the ingredients are properly identified with product name, batch no, material name and quantity.
7.11.4 Check that all the ingredients are present and identified properly with reference to product specification.
7.11.5 Check that humidity / temperature of area (if necessary) is suitable for process & well within the defined limit.
7.11.6 Ensure that BMR/BPR is completed up to the current stage/time.
7.11.7 Ensure that the environmental condition of the area is maintained as given in the respective BMR/BPR and recorded in the relevant entries.
7.11.8 Assure the addition of active ingredients and other excipients under controlled humidity and temperature.
7.11.9 Check that humidity / temperature of area (if necessary) is suitable for process & well within the defined limit.
7.11.10 Ensure that BMR/BPR is completed up to the current stage/ time.
7.11.11 Check that clean protective clothing, gloves and masks are being used.
7.11.12 Check that all relevant documents are complete.
7.11.13 Check and ensure that the status label of previous product on poly bag / equipment is removed.
7.11.14 Ensure that Room/equipment is cleaned as per respective SOP and 'Room / equipment Cleaning Certificate ' status label of area / equipment is affixed.
7.11.15 Ensure that the equipment cleaning is recorded and completed on the relevant entries in the respective Equipment logbook.
7.11.16 Check and ensure all the materials (utensil, tools, container, documents etc.) are removed from area, which were used in previous product.
7.11.17 Ensure that the balancers) are verified and calibrated before the use and the record(s) are completed.
7.11.18 Ensure that the released status of issued materials.
7.11.19 Ensure that the software setting parameter entered in the HMI for the previous batch/product is deleted and clear for next batch setting.
7.11.20 Ensure that Cleaning of the area/equipment is not exceeding its validity period as per production SOP.
7.11.21 If the all requirements are fulfilled, then production and QA shall sign on the respective area checklist as well as sign in the defined place given in respective BMR/BPR if Line clearance found satisfactory.
7.11.22 In case of any failure to comply the line clearance, it shall be dealt with incident & immediately notified to QA Head & Production Head.
7.11.23 After taking corrective action, QA shall ensure line clearance again and then only batch record shall be signed.
8.0 Reference Document
8.1 WHO GMP Guideline trs-986, annex-2
8.2 In-house
9.0 Annexure
9.1
None
10.0 Revision History
|
Version
No. |
Brief Reason for the
Revision |
Effective Date |
Remarks |
|
01. |
New |
|
|
11.0 Training
11.1 Training is required for all concern people
of all departments, trained by Head of Department / Head of Quality Assurance.
