Production

Monitoring of Room Condition, Purpose:

Monitoring of Room Condition, To lay down the procedure for monitoring of Temperature, Relative Humidity (%) and Pressure Gradient at the Production Area.

Monitoring of Room Condition, Scope:

This SOP is applicable for the Production Area of General Block of the XX Pharmaceuticals Limited.

Definitions / Abbreviation:

[][]N/A.

Responsibilities:

[][]The Roles and Responsibilities are as follows :

Operator

[][]To follow the laid down procedure

Executive, Production

[][]To monitor and check the procedure is followed

Manager, Production

[][]To implement this correctly

Manager, Quality Assurance

[][]To approve the Document

Procedure :

Precaution :

[][]Do not use a new hygrometer unless it is calibrated.
[][]When any hygrometer is shifted from one location to another, allow to stabilize the device prior to record the temperature / Relative Humidity (%).
[][]Check the due date of calibration of the hygrometer and magnehelic gauge before taking reading.
[][]Ensure that temperature and Relative Humidity (%) readings are taken before going to operation.

[][]Temperature and Relative Humidity (%) (using Digital Hygrometer)
[][]Ensure that no dust is accumulated over the sensor.
[][]Read the temperature and relative humidity (%) values displayed on the screen of digital/analog hygrometer and record in ‘Temperature, Relative Humidity (%) & Pressure Gradient Records’ (Annexure-I).
[][]Acceptance Criteria:

Pressure Gradient

[][]Read the pressure differential from magnehelic gauge provided and record.
[][]If the reading is not within limit, check whether all the doors are closed.
[][]Observe the second reading.
[][]Even if the second reading is not within the limit, inform the Engineering department for corrective action.

Frequency

[][]Twice in a shift, first before starting the operation and second after four hours.
[][]If the reading is not within limit at any time of operation, inform the Engineering department immediately and take following steps in different areas.
[][]At Dispensing area stop weighing process, close the bags / high density polyethylene (HDPE) drums of raw materials.
[][]At Granulation area, stop transfer process of materials if running and close the SS / HDPE container with lid.
[][]Do not discharge if temperature and relative humidity (%) or pressure gradient are not within limit.
[][]At Blending area, continue blending process if already running.
[][]At Compression area, stop operation and close the tablet SS/HDPE container lid. Do not keep the granules in the hopper during overnight.
[][]Empty the hopper and close the lid of SS / HDPE container.
[][]At Encapsulation area, stop operation and close the capsule SS/HDPE container lid. Do not keep the granules / pellets in the hopper during overnight. Empty the hopper and close the lid of SS/ HDPE container.

[][]At Coating area, continue operation if already running, otherwise stop operation. Do not unload if temperature and relative humidity (%) or pressure gradient are not within limit.
[][]At Powder filling area, stop the operation. Do not keep the granules in the hopper during overnight.
[][]Empty the hopper and close the lid of SS / HDPE container.
[][]At Blister Packing area, close the lid of tablet / capsule container, close the hopper with lid and stop further operation.

Annexure:

Annexure I – Room Condition Monitoring Logbook

Production area Cleaning Procedure, Purpose:

Production area Cleaning Procedure, To lay down the procedure for effective Cleaning of Production area during Product to Product change over, Batch to Batch change over and at the end of day’s operation.

Production area Cleaning Procedure, Scope:

This SOP is applicable for the Production Area of  XX Pharmaceuticals Limited.

Definitions / Abbreviation:

[][]N/A.

Responsibilities:

[][]The Roles and Responsibilities are as follows:

Operator

[][]To follow the laid down procedure

Executive, Production

[][]To monitor and check the cleanliness of area

Manager, Production

[][]To implement this correctly

Manager, Quality Assurance

[][]To approve the Document

Procedure:

Precaution :

[][]Do not clean/disinfect the area when the process is running.
[][]Keep the cleaning agents at the designated place only with proper labels.
[][]Ensure that after usage the wet mops are washed and hanged in hanger in cleaner store &allowed to dry. Ensure other cleaning tools are also hanged in hanger after use.
[][]After use of cleaning agent wash hands, feet and fingers thoroughly with soap & plenty of water.
[][]Ensure that during cleaning all the product containers are closed.
[][]Check and ensure that disinfectant solution prepared is not stored for use for the next day and the residue is discarded by pouring into drain.
[][]At least two different disinfectants are to be used alternatively on weekly basis.
[][]Do not mop the floor after keeping ‘Cleaned’ equipment in clean equipment storage room.

Cleaning Tools / Agents

[][]Portable vacuum cleaner
[][]Cloth & wiper
[][]Potable water and Purified water
[][]Glass Cleaning agent: ‘Clear View’ (Brand Name)
[][]Disinfectant Savlon (Cetrimide + Chlorhexidine Gluconate) / Dettol (Chloroxylenol) / Clotec (Hypochloride).

Preparation of 2.5 % v/v Savlon/ Dettol/Clotec

[][]To make 10 L disinfectant solution take 0.250 L Cetrimide + Chlorhexidine Gluconate/ Chloroxylenol / Hypochloride in freshly collected purified water to make up volume up to 10 L.
[][]Stir well to mix the solution properly.
[][]Prepare the disinfectant solution separately in separate bucket for use in different floor.
[][]Maintain the ‘Disinfectant Solution Preparation Record’ (Annexure – I).

Product to Product Cleaning Procedure (Type – A Cleaning) for Production Area

[][]Type – A cleaning is defined as cleaning procedure followed during product to product changeover.
[][]If the unit/equipment is used for same product it has to be cleaned after 72 hours.
[][]Place the status label ‘TO BE CLEANED’ (As per Form No. SOP/QCOM/008/XI) in the Area.
[][]Clean the ceiling, walls, outer surface of light fixtures, supply diffusers (SD) and return grills (RG) first with portable Vacuum cleaner to remove loose dust using a platform trolley, then with wet mop.
[][]Clean the machine/equipment in Production area as per SOP.
[][]Clean the doors, compressed air lines and other service lines with dry cloth.
[][]Clean the glasses with ‘Clear View’ solution and wipe.
[][]Clean the control panels, electrical wires with dry cloth.
[][]Clean toolbox, Batch Manufacturing Record table, log books, SOP holders, hygrometer, stool / chair with dry cloth.
[][]Clean the floor first with dry mop, then with potable water and mop with disinfectant solution. Finally clean with purified water.
[][]Ensure after inspection for absence of any residue of previous product. If any residue of previous product or extraneous matter is found, re-clean the area using above procedure until the area is free of any residue/ extraneous matter.

[][]Remove ‘TO BE CLEANED’ and affix ‘CLEANED’ (As per Form No. SOP/QCOM/008/IX) label in the cleaned area after approval from Quality Compliance.
[][]Record the cleaning activity in ‘Room Cleaning Log Book’ (Annexure – II).

Frequency of Cleaning

[][]During product to product change over.
[][]After 3 days or 72 hours from the date of use of the equipment or area. If any batch is running and 72 hours time exceeds during the batch running period, cleaning shall be done after the batch is finished. If 72 hours time exceeds after cleaning and the equipment or area is not used, use the equipment or area after performing B-type cleaning.

Batch to Batch Cleaning (Type-B Cleaning) for Production area

[][]Type – B cleaning is defined as cleaning procedure followed during batch to batch changeover of a
same product.
[][]Place the equipment status label ‘PARTIALLY CLEANED’ (As per Form No. SOP/QCOM/008/X) in the area.
[][]First clean the floor, ceiling, walls, outer surface of light fixtures, supply diffusers (SD), return grills, (RG) doors and equipment with portable vacuum cleaner to remove the loose dust. [][]Finally clean the floor with wet mop.
[][]Remove ‘PARTIALLY CLEANED’ and affix ‘CLEANED’ (As per Form No. SOP/QCOM/008/IX) label in the area.
[][]Record the cleaning activity in Room Cleaning Log Book.
[][]Frequency of Cleaning
[][]During batch to batch change over

[][]Cleaning at the End of Day’s Operation
[][]Clean external parts of the machine, and operating panel with dry cloth.
[][]Clean the floor first with dry mop, then with potable water and mop with disinfectant solution. Finally clean with purified water.

Annexure:

Annexure I – Disinfectant Solution Preparation Record.
Annexure II – Room Cleaning Log Book.