SOP Title: Routine Monitoring of Facilities and Utilities
- Objective
To lay down procedure for routine monitoring of facilities and utilities.
- Scope:
This procedure is applicable to manufacturing facility, warehousing and storage area, QC laboratory, packaging area critical and utilities.
- Responsibility:
Officer/executive respective/QA department – To check and verify the facility & utility as per procedure and report to concern department head and QA head if any non conformance is observed.
Head QA/Head of department – To evaluate and analyse the problem, investigation of root cause, ensure CAPA and implementation.
- Accountability:
Head QA/ Head concerned department
- Procedure:
5.1 Definitions:
Contamination: The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or on to a starting material or intermediate during production, sampling, packaging or repackaging, storage or transport.
Cross contamination: Contamination of a starting material, intermediate or finished product with another starting material or product during production.
Mix up: A mistake that result from taking one thing to be another or a wrong action leading to bad judgement or ignorance.
QA Associate: Officer/executive QA Department trained to perform duty as per this SOP.
Production Associate: Officer/executive Production Department trained to perform duty as per this SOP.
Warehouse Associate: Officer/executive Warehouse Department trained to perform duty as per this SOP.
QC Associate: Officer/executive QC Department trained to perform duty as per this SOP.
Engineering Associate: Officer/executive Engineering Department trained to perform duty as per this SOP.
5.2 Procedure:
| 5.2.1 | Buildings | |
| 5.2.1.1 | Ensure separate entry/exit is followed for materials and personnel to prevent cross contamination and/or mix-ups. | |
| 5.2.1.2 | Ensure that the washroom and toilet facilities are separate, maintained at clean and hygienic condition and provided with necessary items like soap, hand dryer etc. | |
| 5.2.1.3 | Ensure that appropriate changing/gowning facilities are provided and followed at the entrance of production area | |
| 5.2.1.4 | Ensure adequate room/area designed for specific operations are used properly | |
| 5.2.1.5 | Ensure segregated areas for waste materials are used | |
| 5.2.1.6 | Ensure lighting, temperature, humidity and ventilation are appropriate for the operations carried out and do not adversely affect product manufacturing, storage or equipment functioning. | |
| 5.2.2 | Structure & Finish | |
| 5.2.2.1 | Ensure that preventive measures have been taken to prevent entry or harbouring of insects, birds, and rodents. | |
| 5.2.3 | Warehouse/Storage Areas | |
| 5.2.3.1 | Ensure that warehouse/storage areas are maintained in a good state of repair, and have appropriate cleaning procedures. | |
| 5.2.3.2 | Check outside doors and receiving docks must minimize exposure to outside environment. Storage racks and materials can be cleaned. Windows are sealed or closed. | |
| 5.2.3.3 | Ensure that storage areas have adequate space for material storage with segregation where needed. | |
| 5.2.3.4 | Ensure only approved materials are dispensed for batch manufacturing. | |
| 5.2.3.5 | Ensure that materials are stored off the floor. | |
| 5.2.3.6 | Check whether materials are spaced to allow cleaning and inspection. | |
| 5.2.3.7 | Labels for different products, strength, dosage forms, etc stored separately with suitable identification. | |
| 5.2.3.8 | Rejected components, materials, and containers quarantined and clearly marked to prevent their use. | |
| 5.2.4 | Production Areas | |
| 5.2.4.1 | Access to the manufacturing area is controlled; no unauthorized person should enter the manufacturing area. Ensure that entry change room(s) manufacturing and packaging area is clean and provide protection from ingress of outside contaminations. | |
| 5.2.4.2 | Ensure that the path or flow of materials from receipt to finished product should be one way. If some materials do cross paths, procedures must be in place to minimize potential mix-up. | |
| 5.2.4.3 | Ensure that the personnel movement within or between departments/areas cannot contribute to contamination from the external environment or internal product dust from one area to another. | |
| 5.2.4.4 | Check whether air locks separate the outside environment from the manufacturing areas. | |
| 5.2.4.5 | Check whether floors/walls are smooth, non-porous, easy to clean surfaces in a good state of repair, resistant to cleaning materials. | |
| 5.2.4.6 | Check whether wall/floor/ceiling junctures are smooth or coved for cleaning. Floors sloped to drain and drains are trapped. | |
| 5.2.4.7 | Check whether ceilings are smooth, cleanable with no holes or crevices. Utilities (electric, water, gas) are sealed at point of entry/exit. If utility service lines are exposed, the surfaces of the pipes, ducts are cleanable. | |
| 5.2.4.8 | Ensure that all equipment are provided with SOPs for operation, cleaning and maintenance. | |
| 5.2.4.9 | Check whether cleaning procedure is in place and followed properly. Cleaning procedure should include cleaning schedules, methods and appropriate cleaning agents. | |
| 5.2.4.10 | Where disinfectants are used to sanitize surfaces such as walls, floors, and ceilings and are rotated according to a written procedure. | |
| 5.2.4.11 | Check whether records of machine usage, cleaning and maintenance are maintained. | |
| 5.2.4.12 | Check whether control of air pressure, dust, humidity and temperature adequate for the manufacture, processing, storage or testing of drug products. | |
| 5.2.4.13 | Check whether air filters are routinely cleaned and replaced as per existing procedure. | |
| 5.2.4.14 | Ensure drains are designed to prevent standing water inside the facility. | |
| 5.2.4.15 | Check whether the procedure for preventing infestation by rodents, birds, insect and vermin’s are followed. | |
| 5.2.4.16 | Check whether sewage, trash and refuse are disposed in a safe and sanitary manner. | |
| 5.2.4.17 | Check whether design and operating precautions are taken to ensure that lubricants and coolant do not come in contact with the contact part to the drug components. | |
| 5.2.4.18 | Ensure that each piece of equipment is clearly marked ‘to be cleaned’ or ‘cleaned’; under maintenance etc. | |
| 5.2.4.19 | Ensure whether equipment is promptly cleaned after use. | |
| 5.2.4.20 | Ensure that each equipment have preventive maintenance status describing due date and servicing date, equipment ID, model, make, authentic signatory etc. | |
| 5.2.4.21 | Ensure whether washing facility for equipment and accessories are maintained in sanitary conditions and do not allow any source of contamination and cross contamination. | |
| 5.2.5 | Packing Area | |
| 5.2.5.1 | Ensure that packing operations are carried out in separate and segregated manner. | |
| 5.2.5.2 | Ensure that access to primary packing area is controlled | |
| 5.2.5.3 | Ensure that materials are handled and transferred in safe and secure manner in order to avoid cross contamination and mix up in packing area. | |
| 5.2.5.4 | Check whether gowning procedure is followed properly during entering the primary packing area. | |
| 5.2.5.5 | Check whether packing operations in primary packing cubicles are carried out in an environment (temperature and humidity) as per product requirement and monitored continuously. | |
| 5.2.5.6 | Ensure that log books of machine usage and cleaning are filled correctly and maintained up to date. | |
| 5.2.5.7 | Ensure that packing cubicle is maintained in clean and sanitary condition to prevent risks of contamination, cross contamination and mix ups. | |
| 5.2.5.8 | Ensure that each piece of equipment is clearly marked ‘to be cleaned’ or ‘cleaned’; under maintenance etc. | |
| 5.2.5.9 | Ensure whether equipment is promptly cleaned after use. | |
| 5.2.5.10 | Ensure that each equipment has preventive maintenance status describing due date and servicing date, equipment ID, model, make, authentic signatory etc. | |
| 5.2.5.11 | Ensure washing area for equipment and change parts are designed and maintained to facilitate adequate cleaning as per approved procedure. | |
| 5.2.5.12 | Ensure that coding operations are performed separately in segregated manner and control measures are being taken. | |
| 5.2.5.13 | Ensure that products and materials are kept in the clean pallets in segregated manner. | |
| 5.2.6 | Quality Control Laboratory | |
| 5.2.6.1 | Ensure that interior surface (walls, floor, and ceilings) are smooth and free from cracks, and permit easy cleaning and disinfection. | |
| 5.2.6.2 | Ensure that safety installation such as shower; eye washer, fire extinguisher etc are working properly in the laboratory. | |
| 5.2.6.3 | Ensure that drainage system facilitate proper maintenance and prevent water logging in the laboratory. | |
| 5.2.6.4 | Ensure that preventive measures have been taken to prevent entry of insects and rodents in laboratories. | |
| 5.2.6.5 | Ensure that all personnel wear laboratory coats or other protective clothing including gloves and face masks and eye protection wherever required. | |
| 5.2.6.6 | Ensure that all laboratory equipment/instruments are identified and labeled with unique ID. | |
| 5.2.6.7 | Ensure that all laboratory instruments are calibrated as per schedule and properly labeled. | |
| 5.2.6.8 | Ensure that all equipment/instruments are provided with SOPs for operation, cleaning, maintenance and calibration and records are maintained | |
| 5.2.6.9 | Ensure that SOPs for handling and storage of test samples, retained samples, reference standards/cultures, reagents are followed properly and records are maintained. | |
| 5.2.6.10 | Ensure that all reagents and solutions in the laboratory are properly identified with a label. | |
| 5.2.6.11 | Ensure that stock solutions, standard solutions, volumetric solutions are prepared as per SOP and records are maintained. | |
| 5.2.6.12 | Ensure that hazardous or poisonous materials are stored and handled as specified in the SOP. | |
| 5.2.6.13 | Ensure that all the personnel working in the departments are trained in their respective job responsibilities and safety system in laboratory and records are maintained thereof. | |
| 5.2.6.14 | Ensure that STPs and SPCs of all raw materials, semi-finished and finished products are available and followed. | |
| 5.2.6.15 | Ensure that SOP for preparation of working standards is available and followed meticulously. | |
| 5.2.6.16 | Ensure that SOP for preparation and sub culturing microbial cultures are available and followed. | |
| 5.2.6.17 | Ensure that laboratory is provided with latest and updated compendia, supplement or addendum. | |
| 5.2.6.18 | Ensure that all the records generated are archived in separate area in secure and safe manner. | |
| 5.2.7 | HVAC System | |
| 5.2.7.1 | Ensure that HVAC service floor is away from the production, warehouse/storage and QC area and do not lead to these areas directly. | |
| 5.2.7.2 | Ensure AHUs, dehumidifiers, duct lines, filters, dampers, exhaust fans etc are placed at strategic points to facilitate easy operation, maintenance and cleaning activities. | |
| 5.2.7.3 | Ensure each AHU/dehumidifier has drawing to indicate its supply system and component arrangements. | |
| 5.2.7.4 | Ensure that critical equipment of HVAC system are identified with a unique ID number. | |
| 5.2.7.5 | Ensure that all the supply lines/ducts are marked with signs to indicate nature and direction of supply. | |
| 5.2.7.6 | Ensure that routine cleaning of filters are carried out as per procedure and records are maintained. | |
| 5.2.7.7 | Check whether filter cleaning area is maintained under negative pressure and adequate preventive measures are being taken to prevent dust. | |
| 5.2.7.8 | Ensure that facilities provided for filter cleaning like cleaning machine, water supply, compressed air supply, drains and drying section are in proper working condition. | |
| 5.2.7.9 | Ensure that cleaned and un-cleaned filters are handled and replaced in safe manner and procedure has been established. | |
| 5.2.7.10 | Calibration procedure for measuring devices like pressure gauges, timers, thermometers etc are followed and records are maintained. | |
| 5.2.7.11 | Ensure that a scheduled preventive maintenance programme is followed for critical equipment and records are maintained. | |
| 5.2.7.12 | Ensure that SOP for operation, cleaning and maintenance for all critical equipment are available at the location and followed meticulously. | |
| 5.2.7.13 | Check whether break down records of production equipment are maintained. | |
| 5.2.7.14 | Ensure that approved spares/parts where necessary are kept to maintain continuous operation of the system. | |
| 5.2.8 | Water System | |
| 5.2.8.1 | Ensure that the current schematic drawing of the water system is in place. | |
| 5.2.8.2 | Ensure that PW generation area is maintained in clean and sanitary condition. | |
| 5.2.8.3 | Ensure that SOPs for operation, cleaning, sanitization, regeneration and maintenance are available for all equipment involved in the purification steps at the location. | |
| 5.2.8.4 | Ensure there is no any leakage in the PW generation and distribution loop line. | |
| 5.2.8.5 | Ensure that all the equipment are properly labelled with name, ID number, maintenance and calibration status etc. | |
| 5.2.8.6 | Ensure that sanitization of PW tank and distribution system is routinely carried out as per current procedure and records are maintained. | |
| 5.2.8.7 | Ensure that softener is regenerated periodically as per current procedure and records are maintained. | |
| 5.2.8.8 | Ensure that chlorination and de-chlorination procedure is followed and records are maintained. | |
| 5.2.8.9 | Ensure that chemicals for chlorination, de-chlorination and other treatments are analysed and approved by QC department prior to use. Check approved label. | |
| 5.2.8.10 | Ensure that all measuring devices i.e. pressure gauges, timer, conductivity meter, pH meter, ampere meter, voltmeter, flow meter etc are calibrated and records are maintained. | |
| 5.2.8.11 | Ensure that sampling procedure for chemical and microbiological analysis of water are followed meticulously and records are maintained. | |
| 5.2.8.12 | Ensure planned preventive maintenance programme is available to the engineering department and records are maintained. | |
| 5.2.8.13 | Ensure that RO membranes are cleaned/replaced periodically and records are maintained. | |
| 5.2.8.14 | Ensure mixed bed is regenerated periodically as per procedure and records are maintained. | |
| 5.2.8.15 | Ensure tanks are cleaned and sanitized appropriately as per established procedure and records are maintained. | |
| 5.2.8.16 | Ensure that each sampling points are identified and labelled properly and preventive measure are being taken during sampling. | |
| 5.2.8.17 | Ensure that necessary approved spare parts are available in the engineering department where applicable. | |
| 5.2.8.18 | Ensure that operating ranges and alarm system for critical parameters have been established and appropriate troubleshooting action plan is in place. | |
| 5.2.8.19 | Ensure that vent filter is routinely subjected to integrity testing and integrity test records are maintained. | |
| 5.2.8.20 | Ensure that documentation related to deviation, change control, OOT, investigation, incident in the water system are maintained. | |
| 5.2.9 | Compressed air system | |
| 5.2.9.1 | Ensure that current schematic drawing of compressed system is in place describing details of components functions. | |
| 5.2.9.2 | Ensure that compressed air equipment are maintained in cleaned condition and properly labelled with name and ID number. | |
| 5.2.9.3 | Ensure that SOPs for operation, cleaning, calibration and maintenance of all equipment are at the location. | |
| 5.2.9.4 | Ensure that sampling points of compressed air system are clearly identified and labelled. | |
| 5.2.9.5 | Ensure that current sampling procedure for compressed air system and records are maintained. | |
| 5.2.9.6 | Ensure that planed preventive maintenance programme is followed for CAS and records are maintained. |
- Abbreviation:
| Abbreviation | Expansion |
| SOP | Standard Operating Procedure |
| QAD | Quality Assurance Department |
| HVAC | Heating Ventilation and air conditioning |
| AHU | Air Handling System |
| ID | Identification |
| PW | Purified Water |
| OOT | Out of Trend |
| CAS | Compressed Air System |
*Note – Ready to use SOP available in “DOWNLOAD” Section.