totality features or conformance to specifications of a product

quality is everybody's business

part of quality assurance whic ensures that products are consistently produced and controlled to the quality standards appropriate for their intended use

regular periodic quality reviews of al registered drug products to verify consistency of the existing process and to ientify product and process improvements

a systematic process for the assessment, control, comunication, and review of risks to the quality of the product

selecting appropriate number from the population

contains the detailed requirements and must be confirmed

-conducts the required tests -inspects raw materials, in process products, finished products

-audit and monitoring -ensures policies are followed -cooperates with regulatory agencies -prepares sop

udesired characteristic of a raw material or product which indicates that it failed to conform to rhe standards

removal of the product from themarket because it is either defective or harmful

glucagon, atropine

oxytocin

PTH

digitalis

cod liver oil chorionic gonadotropin corticotropin vasopressin

heparin, protamin sulfate

insulin, tobocurarine

lacrobacillus plantarum

lactobacillus leichmannii

micrococcus luteus

e. coli

s. aureus

k. pneumoniae

b. subtilis med

hydrogen sulfide ts

silver diethyldithiocarbamate ts

ammonium thiocanite ts

silver nitrate ts

barium chloride ts

-fastest -used at least 25g of sample

measure of flowability -maximum angle potential between the surface of the pile of the powder and the horizontal plane

measure of compressibility

measure of flowability

measure dissolution, disintegration, and bioavailability

4-10 kg

2-3 kg

7/8-10kg

>10kg

crude method/ sharp snap

spring

air pump// hydraulic pressure

pliers llike

suspended motor driven weight

motor-driven anvil cushes tablet horizontally

-identical appearance -faciliitate packaging -accuray for tablet counting machines

uncoated/ir tablet in water

capsule in water

sl tablet in water

buccal tablets in water

ECT in water

ETC in stimulated gastric fluid

ETC in stimulated intestinal fluid

• Test for measuring the amount of time required for a given % of drug substance in a tablet to go into solution • Equipment: Vessel with cover, water bath maintained at 37±0.5 °C metallic drive shaft or Paddle.

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o ≥ 25mg API per dose and comprising ≥ 25% by wt. of dosage unit o Sample: 20 uncoated compressed tablets

o Ensures formulation potency o <25 mg API per dose and comprising <25% by wt. of dosage unit o Sample: 10 units (assay individually); 20 units on retest o Acceptance Criteria: 85-115% API (100±15)

microbial content for opthalmic

mirobial content for topica dosage forms

microbal content for urethral, vaginal

• For semisolids with labeled content of NMT 150g or 150ml • Sample: 10 containers (assay individually); 20 containers on retest 𝑛𝑒𝑡 𝑐𝑜𝑛𝑡𝑒𝑛𝑡 = 𝑖𝑛𝑖𝑡𝑖𝑎𝑙 𝑤𝑒𝑖𝑔ℎ𝑡 − 𝑓𝑖𝑛𝑎𝑙 𝑤𝑒𝑖𝑔ℎ𝑡 • Initial wt.: container with sample (unlabeled, cleansed, then dried) • Final wt.: empty container (heated at 100°C for 5 mins then cooled) • Acceptance Criteria: o Aerosols ▪ <60 g or 60 ml: >90% ▪ ≥ 60 g or 60 ml: > 95% o Non-aerosols ▪ Net content > labeled content

• Applicable for liquid products NMT 250mL • Sample size: 10 containers; 20 containers on retest • Procedure: (Angle: 30°; prevent air-bubble formation) • Single unit: drain in 5 seconds • Multiple unit: drain in ≤30 mins

ideal: 100% with minimum agitation

measure of resistance to flow -should not be too fluid nor too viscous

reulsive forces between particles

dye solubility in o/w

dye solubility in w/o

uv flourencence in w/o

uv flourencence in o/w

conductivity in w/o

conductivity in o/w

cobalt chloride in w/o

cobalt chloride in o/w

b. stearothermophilus

b. subtilis

b. pumillus

p. diminuta