SELF INSPECTION CHECKLIST FOR DPI (DRY POWDER INJECTION)
CHANGE ROOM:
- General Area cleanliness
- Entry /Exit procedure & Pictorial diagram
GENERAL AREA:
- General cleanliness
- Area differential pressure records
- Equipment status
- Labeling status
- Use of protective equipment’s (e.g. Hand gloves, nose masks etc.)
- Machine uses and clean log record
- Temperature and relative humidity record of the area
- Status of batch record of the product being processed
- Identification of utility services
- How the facility for Injection designed and constructed to prevent cross contamination and mix-ups.
- Whether the manufacturing area have entrance through double air lock facility.
- Whether in the manufacturing area walls, floors and ceiling are impervious, non-shedding, non-cracking, coved at all junctions.
- Whether the doors and windows and light fixtures are flushed, made up of non fiber shedding material.
- Whether fly catcher and/or air curtain has been provided at strategic suitable points.
- Whether the drains are provided with traps to prevent back flow.
- How drains are maintained.
- Whether the production area is cleaned and sanitized at the end of every production process. If yes, whether records maintained.
- (How the area is sanitized.
- How sanitization procedures controlled).
- What is the Sanitizing Agent for cleaning
- What is the material of construction of tanks, containers, Pipe work and pumps?
- How tanks, pipe works, and other containers sanitized.
- Whether the pipelines and services have any dust lodging surface.
- Whether microbial monitoring of the area is carried out.
- Whether use of glass containers is restricted. If used which type of glass container used
- Whether furniture’s are of stainless steel and are capable of cleaned effectively.
- Decartoning Procedure
- How sterilize vials & rubber Plug
- What is the sterilizing agent of Flip off Seal
- Sterilization record of Vials, Flip off Seal & Rubber Plug
- Temperature record of DHS & Autoclave
- Cleaning procedure of garments used in manufacturing
- Which type of rubber stopper used for lyophilized product
- Whether cleaning of vials, seals, rubber plug etc. are carried out by suitable machine/devices equipped with high pressure air, water.
Purified Water/Water for Injection:
- Whether the Microbial quality of purified water/ Water for Injection is monitored routinely.
- (What is the in house limit of CFU / ml of purified water & Water for Injection).
- Whether water is tested for freedom from Pathogen on daily basis. If not what is the schedule.
- Whether the unit has written procedure for operation and maintenance of purified water/Water for Injection system. (Specify the method).
- Weather Water for injection stored in steam jacketed stainless steel container
ALSO READ – RISK ASSESSMENT PROTOCOL FOR DEPYROGENATION TUNNEL
Manufacturing:
- Cleaning of Aseptic Area
- Weather UV light available in aseptic dress cabinet
- What types of clothing’s are worn by personnel in manufacturing area?
- Whether the tanks have clean in place facility. If not how tanks are cleaned to prevent accumulation of residual microbial growth and cross-contamination.
- Whether materials like gunny bags or wooden pallets are allowed in manufacturing areas.
- Whether separate manufacturing area has been provided,`
- Specify the room temperature requirement in the manufacturing area.
- Cleaning of Membrane Holder
- Rinse test record for manufacturing.
- Rinse test record for filling m/c.
- Working of LAF
- Nitrogen purging during filling
- Weather filter sterilized periodically
- Solution filtered through
- Integrity of filter verified/confirmed during manufacturing
- Log book status for all machines.
- Visual inspection checking person rotation frequency.
- Eye test report of visual inspection checking person.
- Cleaning of Filter
VIAL LABELLING AND PACKING AREA
- General cleanliness of corridor
- Equipment status
- Labeling status
- Arrangement of primary packaging materials
- Arrangement of secondary packaging materials
- Line clearance procedure
- Identification of utility services
- Labeling status
- Status of batch record of the product being packed
- Scrap disposal procedure