Line Clearance Procedure, Purpose :
Line Clearance Procedure, To ensure that the area and equipment to be used for the dispensing, manufacturing and packing of products are free from remnants of previous product/batch.
Line Clearance Procedure, Scope :
This procedure is applicable for clearance of dispensing, manufacturing, packing area & equipments at XX Pharmaceuticals Limited (Both General and Sterile Block).
Definitions / Abbreviation:
[][]N/A
Responsibilities:
[][]The roles and responsibility is as follows:
Quality Assurance Personnel
[][]Responsible to perform the activities as per SOP.
Concerned department
[][]To maintain procedure as described in SOP
Manager, Quality Assurance
[][]Approval of the SOP.
[][]To ensure that the implementation of the procedure as per SOP.
Procedure:
Dispensing:
[][]Before start of dispensing of raw material/coating material Production Executive shall check the following and keep record in BMR.
[][]Area cleanliness, absence of irrelevant/ foreign material
[][]Equipment cleanliness
[][]Removal of material of previous batch/product from dispensing area
[][]Balance calibration records, daily accuracy check/ function check of balance
[][]Entry in Log book
[][]Status label of material/ component
[][]Cleanliness of container of material to be dispensed.
[][]Quality Assurance Executive shall monitor and then provide counter check/ signature to ensure that line clearance checking has been performed properly by dispensing people and all above stated parameters are satisfactory.
Manufacturing:
[][]For Granulation/ Compression/ Blending of Powder or Pellets/Coating
[][]Before start of any manufacturing operation concerned Production Executive shall check the following parameters and keep the records in BMR.
[][]Area cleanliness, absence of irrelevant/ foreign material
[][]Equipment/ machinery cleanliness
[][]Removal of material of previous batch/product from granulation/ compression/ blending/ coating area.
[][]Balance calibration records, daily accuracy check/ function check of balance
[][]Room Temperature and % Relative Humidity of the granulation/ compression/ blending/ coating area (if applicable)
[][]Entry in Log book
[][]Room display/ Product display
For Powder for Suspension/ Encapsulation:
[][]Before start of any manufacturing operation concerned Production Executive shall check the following parameters and keep the records in BMR.
[][]Area cleanliness, absence of irrelevant/ foreign material
[][]Equipment/ machinery cleanliness
[][]Removal of material of previous batch/product from area
[][]Balance calibration records, daily accuracy check/ function check of balance
[][]Room Temperature and % Relative Humidity of the manufacturing area (if applicable)
[][]Entry in Log book
[][]Room display/ Product display
Packaging:
[][]Before start of any packaging operation concerned Production Executive shall check the following parameters and keep the records in BPR.
[][]Printing Line Clearance
[][]Name of the previous product (to be recorded)
[][]Batch No. of previous product (to be recorded)
[][]Area cleanliness, absence of irrelevant/ foreign material
[][]Entry in Log book
[][]Room display/ Product display
Packaging Area Equipment Clearance:
[][]Area cleanliness, absence of irrelevant/ foreign material
[][]Equipment/ machinery cleanliness
[][]Removal of material of previous batch/product in packaging line
[][]Room Temperature and % Relative Humidity of the packaging area (if applicable)
[][]Entry in Log book
[][]Room display/ Product display
Annexure:
N/A