Lab - RMP,CAPA,SOP, equipment, etc. Flashcards
mix liquids, promote chemical reactions and increase heat or cooling transfers.
Agitators
solvent recovery and other evaporation applications.
Blowers
Apply heat energy to water to create steam
Boilers
filling polishing, and sorting capsules.
Capsule equipment
printing information like drug names or dosage on the capsules or tablets.
Capsule and tablet printers
Separate liquids of different densities, or for separation of liquids from solids.
Centrifuges
lower temperatures quickly
Chillers
coat tablets or capsules with films like a sugar film.
Coaters
cooling liquids or condensing steam.
Cooling towers
drying liquid preparations into powders or granules.
Dryers and Granulators
transfer heat from one medium to another.
Heat exchangers
Visual inspection of products as they move along through rotating rollers.
Inspection machines
Detect tramp metal (bits of metal like nuts, screws, or broken fragments of machinery) that may have contaminated the product.
Metal detectors
blending and particle size reduction.
Mixers
providing necessary heat or drying.
Ovens
Particle size reduction equipment for granules.
Pulverizers / Cone mills
produces tablets.
Tablet press
removes dust created in the tablet press also used to polish tablets
Tablet deduster
sieves powders or granules.
Sifters
spray coats liquid onto a powder.
Spray coating machines
holds liquids.
Tanks
pack tablets, capsules, softgels, injection solutions, syringes and other small medical items into blister packs.
Blister packers
are also available to recover tablets, capsules or softgels from blister packs.
“Deblistering” machines
fills bottles with liquids or containers with tablets, capsules or softgels.
Bottling and filling lines
place caps onto filled bottles or containers of medicines.
Cappers
fill small medicine boxes with blisters packs, fold and insert leaflets, and close, code, and seal the box.
Cartoners
Counts capsules, tablets, softgels and any other small, solid items.
Counters
Seals aluminum foil seals to the bottle mouth.
Induction Sealers
attaches or prints labels onto the packaging of boxes, bottles, containers, tubes etc.
Labeling equipment
fills and seals tubes of ointments, creams and gels.
Tube fillers
Premises
➢ Situated in environment that protects manufacture, presents minimal risk of causing contamination and materials.
➢ Carefully maintained, ensuring that repair and maintenance operations do not present any hazard to the product’s quality. They should be cleaned and where applicable, disinfected according to written detailed procedures.
➢ Lighting, temperature, humidity and ventilation should be appropriate.
➢ Designed and equipped to afford maximum protection.
➢ Production, storage and quality control areas should not be used as right of way by personnel not working in these areas.
N/A
Significant and highly catastrophic impact on product
CRITICAL - 1
Significant losses and respectively addressed management intervention required
HIGH - 2
Loss of operating capability, long term and problem causes adverse effect
MODERATE - 3
Impact on operation and efficiency, but limited
MINOR - 4
Very minor or no impact on operations and quality product efficacy
INSIGNIFICANT - 5
Elimination of the cause or causes of an existing nonconformity or undesirable situation in order to
prevent recurrence.
Corrective Action
Identification and elimination of the
cause(s) of potential nonconformities in order to prevent
occurrence.
Preventive Action
CAPA FRAMEWORK:
PLAN - define root cause
DO - Research solution
CHECK - verify solution works
ACT - implement solution
are used particularly in food
processing, medical device development and manufacturing, and pharmaceuticals.
CAPA processes
is the quality system regulation that requires corrective and preventive procedures to be documented in
medical device manufacturing facilities.
FDA 21 CFR 820
•Promptly identify and document the problem
•Implement a correction or containment or temporary repair
•Find the cause of the issue
•Determine the solution that will prevent a recurrence
•Implement the corrective action and ensure that everything is documented.
•Verify that the action continues to be effective and that the problem does not recur.
N/A
Consequences of Noncompliance With Manufacturing SOPs:
Lack of quality control
Low productivity
Subjective performance evaluations
Communication breakdown
Increased risk of accidents
Manufacturing SOPs help produce high-quality products consistently
Lack of quality control
Manufacturing SOPs are designed to improve efficiency
Low productivity
SOPs clearly define worker tasks and responsibilities
Subjective performance evaluations
SOPs communicate process updates
to workers
Communication breakdown
Safe work practices are often
integrated into manufacturing SOPs
Increased risk of accidents
MODEL FORMAT FOR AN
EFFECTIVE SOP:
Header
1. Purpose
2. Scope
3. References and Related Documents
4. Definitions
5. Roles and Responsibilities
6. Procedure
7. Appendices
8. Revision History
Approval Signature
