Pharmaceutical Differences

Disintegration vs Dissolution

Disintegration	Dissolution
Disintegration: Measuring the breakdown of a dosage form into smaller particles.	Dissolution: The process of dissolving a substance in a solvent.

Ampoule vs Vials

Ampoule: Contain single dose

Vial: May contain multiple dose

Ampoule: Smaller volume than vials

Vial: May larger volume size than ampoule

Ampoule: Ampoule is sealed at the top of the neck

Vial: Vials are sealed with a screw on tap or rubber plug.

Ampoule cannot be resealed onnce it is opened

 using heat and has to be cracked open to access the product.

Ampoule cann't be reused.

Infusion vs Injection

Infusion: An infusion is when fluids,  medication or blood is given through a catheter directly into vein or bloodstream at usually slow rate.

Injection: An injection refers to the administration at medication using a needle and syringe at rapid rate.

Infusion: The gravitational force is used in infusion where bags & hanger are used.

Injection: Pressure is used to push the drug into bloodstream

Infusion: Drug is administered into blood stream via vein at slow rate.

Injection: Drug is administered into bloodstream via vein using syringe at rapid rate. 

Chapter: Quality Assurance

Quality Control vs Quality Assurance

QC: Quality control is the operational technique and activities that are used to fulfill requirements for quality.

QA: Quality assurance is a planned and systematic set of activities necessary to provide adequate confidence that a product or service will satisfy given requirements for quality.

QC = Test + Assessment

QA = Product design + GMP + QC + Quality goal activites

QC is the responsibility of the tester

QA is the responsibility of the entire team.

QC implements the process.

QA helps establish the process.

QC improves the development of a specific products service.

QA improves the process that is applied to multiple products that will ever be produced by a process.

Validation vs Qualification

⇨ Validation:  Validation is establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.

⇨ Qualification:  Qualification is the planning, carrying out and recording of tests on equipment and system,  which form part of the validated process, to demonstrate that it will perform as intended.

⇨ Validation: Without validation, qualification will no complete sequently.

⇨ Qualification: Without qualification, validation will no complete.

⇨ Validation: Validation is conduct for a process, method or system.

⇨ Qualification: Qualification is conduct for equipment that produces a result meet acceptance criteria.

⇨ Validation: Validation is overall process done to follow GMP.

⇨ Qualification: Qualification is a suitable chapter in validation, which covers the instrumentation, documentation, installations.

Out of Specification vs Out of Trend

⇨ OOS indicates that the specification of the product will be outside the upper or lower limit.

⇨ OOT indicates that trend of the product exceeds the 80% of the specification limit, will be treated as out of trend.

⇨ OOS needs correction.

⇨ OOT needs prevention.

⇨ OOS means the batch is failed to meet the specification.

⇨ OOT is the product complies to the specification, however is out of trend compared to other batches results.

⇨ OOS is pharmacopeia requirement.

⇨ OOT is in-house requirement and also consistency of results reprents.

Document vs Record

⇨ A document is a written, drawn, presented or recorded representation of thoughts.

⇨ Records are historical files that provide proof of existence.

⇨ It is an editable.

⇨ Records are not editable and cannot be recreated.

⇨ Document need updaing.

⇨ Records are permanent, do not change.

⇨ Documents can be changed and revised as needed.

⇨ Records can be never changed.

PIC/S vs PIC

⇨ PICS: Pharmaceutical Inspection Cooperation Scheme

⇨ PIC: Pharmaceutical Inspection Convention

⇨ PIC/S: PIC/S is an informal arrangement.

⇨ PIC: PIC is a formal arrangement

⇨ PIC/S: PIC/S has no legal status

⇨ PIC: PIC has legal status

⇨ PIC/S:. between health authorities and Pharmacrutical company

⇨ PC: Treaty between European countries/ Treaty between vountries

⇨ PIC/S: Exchange of information

⇨ PIC: Mutual recognition of inspections

Potency vs Efficacy

Comparative measure of different doses of two drugs that are needed to produce the same effect is called potency.

Ability of drug after binding with receptor to initiate change which leads to effects is called efficacy.

Potency: It is the amount of drug in relation to its effect.

Efficacy: It is the capacity of a drug to produce an effect and refers to maximum such effect.

Potency does not help to choose among drugs.

Efficacy helps to choose among drugs.

Potency: It is absolute potency.

Efficacy: It is therapeutic potency.

Potency determines the administered dose of the chosen drug.

Efficacy determines clinical effectiveness of a drug.

Drug vs Medicine

A drug is any substance that acts on the living body to alter the physiological process and are used for prevention, diagnosis, control and treatment of disease.

Medicine is the formulated form of drug having definite dose, dosage form, leveling and packaging.

Drug is a single active ingredient

Medicine contains more than one ingradient.

Drug has no form and dose.

Medicine has a suitable form and dose.

Drug is used for prevention, diagnosis and treatment.

Medicine is used for therapeutic treatment