Final Exam nga naka INC Flashcards
Define emergency
a potentially life-threatening
situation usually occurring suddenly
and unexpectedly
Define disaster
a sudden, calamitous event bringing
great damage, loss or destruction.
Differentiate emergency and disaster.
Emergency
- a potentially life-threatening
situation usually occurring suddenly
and unexpectedly.
Disaster
- a sudden, calamitous event bringing
great damage, loss or destruction.
2 Types of Emergencies
Man-made emergencies
- events caused by man’s negligence in
handling his technology.
Natural emergencies
- events that are caused by the forces of
nature.
Examples of Man-Made Emergencies
❑ Chemical Leak / Spill
❑ Structure Collapse
❑ Industrial / Community Fire
❑ Construction Cave-In
❑ Major Transportation Accident
❑ Public Demonstration
Examples of Natural Emergencies
❑ Drought
❑ Floods
❑ Volcanic Eruption
❑ Earthquake
❑ Thunderstorms
Cyclical Nature of Emergency Management
Prevention
Preparedness
Response
Recovery
Emergency Prevention
The practice of activities designed to
prevent accidents and emergencies from
occurring.
Procedures of Emergency Prevention
Procedures:
❑ Fire Prevention
❑ Safety and Health Review
❑ Inspection
Emergency Preparedness
Encompasses all activities that are necessary
to prepare people and organizations to
respond to emergencies and disasters.
Procedures of Emergency Preparedness
Procedures:
❑ Personnel Training
❑ Drills and Exercises
❑ Supplies and Equipment
❑ Protection of Records
❑ Mutual Aid
EMERGENCY ACTION PLAN
Emergency design plan is a written set of
instructions that outlines what workers
and people at workplace should do in a
emergency
Emergency Response
Follows preparedness and involves life
saving and protection activities that are
implemented during an emergency.
Procedures of Emergency Response
Procedures:
❑ Direction and Control
❑ Communications
❑ Emergency Shutdown Procedures
❑ Fire and Spill Procedures
❑ Facility Evacuation
❑ Security Considerations
❑ Public Relations and Emergency Information
❑ Coordination between Facility and Offsite
❑ Agencies
Emergency Recovery
Embodies all activities necessary to bring
the organization back to normal or routine
operations.
Elements of an Emergency
Preparedness Program
➢ Review Hazard
➢ Evaluate Resources
➢ Develop Emergency Plan & Procedure
➢ Integrate with community plan
➢ Conduct training
➢ Educate the public
➢ Conduct drills and exercises
EMERGENCY RESPONSE TEAMS
DURING AN IMMINENT EMERGENCY
Security
Fire Control
First Aid
Damage Assessment and Recovery
Emergency Service
Supplies
Procedures of Emergency Recovery
Incident Investigation
Damage Assessment
Cleanup and Restoration
Business Interruption
Claims Procedures
4 Stages of Emergency Procedure
Preliminary Action
- the preparation of a plan tailored to meet the specific
requirements of the side, product and surroundings
Action when emergency is imminent
❑ This stage will feature the assembly of emergency key
personnel
❑ Advance warning to external authorities
Action During the Emergency
❑ Decision making personnel has the authority and is
responsible for the precise and rapid judgements to
ensure that appropriate actions follow the decisions
made
Ending Emergency
❑ A procedure for declaring plant, systems and specific
areas safe
❑ Declaration that processes and operation may
continue
What is GMP?
Part of a quality management system
to ensure that products are consistently
produced and controlled to the quality
standards appropriate to their intended
use and as required by the marketing
authorization.
What is cGMP?
Accordingly, the “C” in CGMP stands for “current”, requiring companies to use technologies and systems that are up-to-date to comply with the regulations.
Difference bet GMP and cGMP
GMP
- covers the required standards of an industry.
- less expensive to implement and maintain.
- minimum standards required for an industry.
cGMP
- ensures that a company is following the latest regulations.
- more expensive due to additional testing and state-of-the-art technologies.
- companies make sure that they are compliant with the most recent rules and regulations.
Objectives of cGMP
- cGMP regulations assure that quality is built into the design and manufacturing process at every step.
- Manufacturing facilities are in good condition.
- Equipment’s are properly maintained and calibrated.
- Employees are qualified and fully trained.
- Processes that are reliable and reproducible.
Personnel Guidelines on cGMP
- Personnel must be qualified and trained for their roles.
- Written procedures (SOPs) should be followed.
- Accurate and detailed documentation is essential.
- **Quality control and quality **assurance personnel play critical roles.
- Ongoing training and staying current with industry standards are required.
- Responsibility, accountability, and reporting deviations are important.
- **Hygiene and gowning standards **must be followed to prevent contamination.
- Effective communication and collaboration among personnel are essential for maintaining cGMP compliance. Compliance ensures product safety and quality in pharmaceutical manufacturing.
Equipment guidelines on cGMP
- Equipment shall be located, designed, constructed, adapted, and maintained to suit the operation to be carried out.
- Equipment should be calibrated, checked, labeled, sterilized, and accompanied with SOP.
Facility guidelines on cGMP
- Premises must be located at a place where it
can minimize risks of cross-contamination and can support efficient operations. - Minimize risks of errors
- Permit effective cleaning and effective maintenance
- Avoid cross-contamination, build-up of dirt and dust
- Maximum protection against entry of insects, birds, and animals
- Finishing floors, walls, and ceilings should be smooth, impermeable, hard-wearing, easy to clean
- Buildings and areas shall be of suitable size to facilitate production, cleaning, and maintenance properly.
- Lighting: Adequate lighting shall be provided in all areas
- Proper Ventilation, air filtration, air heating and cooling
- Plumbing: drains shall be of adequate size and, where connected directly to a sewer
- Adequate Washing and toilet facilities
- Sanitation: buildings should be free of infestation (rodents, birds, etc)
- Maintenance: each area shall be maintained in a good state of repair
Internal Inspection
A regular independent inspection is necessary to evaluate the manufacturer’s compliance with cGMP in all aspects of manufacturing
BMR and MFR
Batch Manufacturing Record (BMR) and Master Formulation Record (MFR)