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Standard Operating Procedure (SOP) for Line Clearance (LC) during the manufacturing process of pharmaceutical drug products. The term line clearance is used for the documented act of conducting any necessary removal of products and materials from a manufacturing/ packaging line to prepare the line for the next production.

Line Clearance (LC) Procedure

1.0   Objective :

• • To lay down the procedure for Line Clearance.

2.0   Scope :

• • This SOP is applicable in Production/Packing and Stores (Dispensing of raw materials) before starting a new process at the pharmaceutical manufacturing plant.

3.0   Responsibility :

4.0   Accountability :

• • Head of Respective Department: For system compliance.

5.0   Procedure for Line Clearance :

• • Line clearance:

• • The term line clearance is used for the documented act of conducting any necessary removal of products and materials from a manufacturing/ packaging line to prepare the line for the next production.

• • Mix-Up:

• • Accidental mixing of raw material/ intermediate/ finished product/ packing material of one product/batch to another product/batch

• • Cross Contamination :

• • Contamination of a starting material, intermediate product, or finished product with another starting material or product during production

• • Contamination :

• • The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or onto a starting material, or intermediate or finished product during production, sampling, packing or repacking, storage or transport.

Related: Cross Contamination, Mix-Ups & Microbial Contamination

• • Line clearance of each area/equipment shall be done to control:

• • • Contamination & cross-contamination.

• • • Mixing of products or batches.

• • Before starting each operation Production Chemist or Stores Officer should check the area/equipment used.

• • Check the area as per the checklist attached in BPR / BMR and put their initial.

• • If any point is not applicable then write NA.

• • After checking inform to QA chemist to release the area/equipment for the next process.

• • QA chemist should verify the area/equipment and record the observation in the checklist.

• • Visually check the cleanness of the area/equipment by using the battery torch during the line clearance where ever required.

• • If all the points comply, the QA chemist shall release the area/equipment for the next processing and put the initials with the date.

• • If the area/equipment does not comply with the checklist, inform to Production Chemist or Stores Officer to take necessary corrective action.

• • After the corrective action, the QA chemist shall verify the same and release the area/equipment for the next processing if the things comply.

• • Re-line clearance:

• • Manufacturing areas:

• • Re-Line clearance during manufacturing operation shall be done in the given below condition.

• • • After machine/equipment breakdown followed by breakdown maintenance work.

• • • If any non-conformance reported during line clearance and during operation.

• • The batch shall be continued after doing the line clearance as per the Annexure-IV which shall be conducted either by the next production chemist/Officer or by IPQA.

• • Packing area:

• • Reline clearance during packing operation shall be done in the given below condition:

• • • Change over from sale to P.S. or institution or vice versa.

• • • If the packing process continues to the next day.

• • • After machine breakdown followed by breakdown maintenance work.

• • • Re-line clearance shall be done using Annexure-I or Annexure-II as per the above procedure.

• • Controlled copies of these annexures shall be issued by QA as and when required.

• • In case some deficiencies are noticed during checks and verifications,

• • Then quick corrective action is taken to address the deficiency, and

• • only after rectifying the deficiency, line clearance shall be given

• • Dispensing Area:

• • Re-Line clearance during dispensing operation shall be done in the given below condition:

• • • After machine breakdown followed by breakdown maintenance work.

• • • If the dispensing process continues to the next day.

• • • Re-line clearance of the dispensing area shall be done using Annexure-III.

• • During batch changeover of campaign manufacturing in the product:

• • Each equipment shall be cleaned as per the respective SOP and there shall be no loose/stuck bulk powder.

• • If any shall be removed.

• • General cleaning of area and riser filter/grill shall be cleaned and

• • No loose powder shall be there.

• • If cleaning of the filter is defined in the checklist, it shall be marked NA “Not Applicable”

6.0   Reference – Line Clearance :

• • Revised Schedule M

• • Volume 4:   EU Guidelines to Good Manufacturing Practice Medicinal Products for
    Human and Veterinary Use, Chapter 5 Production.

7.0   Glossary

• • QA: Quality Assurance

• • SOP: Standard Operating Procedure

• • BMR: Batch ProductionRecord     (Related: SOP for BMR/BPR Review)

• • BPR: Batch Packaging Record or Batch Processing Record

• • P.S.: Physician Sample

8.0   Annexures of SOP for Line Clearance (LC) :

Annexure I: Format for Re-line Clearance for Oral Liquids.

Annexure-II: Format for Re-line Clearance for Tablets & Capsules.

Annexure III: Format for Re-line Clearance for Dispensing.

Annexure-IV: Format for Re-line Clearance of production area during shift break.