Standards, Specifications, Defects and Quality Variations

Quality Characteristics

• are interpreted by descriptive words and measurements

Characteristics

• are subject to variation

Quality variation

• which is not confined within a specific range, tolerance or limit, will grow to uncontrolled magnitude and will encourage the proliferation of errors; thus producing a defective product

Materials, Methods, Machines, Men

Errors may be due to chance or assignable cause such as:

Formula

• this is concise and precise statement of the ingredients that comprise the product, together with the percentage and/or weight of each

Raw material specification

• this should enumerate the of all the materials that go into the product and the permissible range of purity of each ingredient.

• deviation beyond this range may be expected to cause failure of the product to function as planned or, at least, result in an undesirable lack of uniformity.

Standard Operating Procedure

• this is a step by step method on how to go about a job

• it must spell out all information and instructions that assure that variations in production from day to day and week to week will be held within acceptable established ranges

Finished Product Specification

• this should cover all characteristics that affect the proper performance, purity, safety and stability of the product

• tolerances may be minimum, maximum, or both, depending on the nature of the situation

Packaging Material Standard

• this should be set for everything that goes around the product, i.e., bottles, cans, aluminum foil, cellophane, jars, caps, cap liners, labels, printed inserts, cartons, wrapping papers, and shipping cases

Testing Methods

• these are indispensible in ensuring conformity to standards

• since they play such a vital role, testing procedures must be standardized so that they yield results of comparable precision and accuracy in the hands of different operators and laboratories

• this tests must be validated to ensure precision and accuracy on application

United States Pharmacopeia and National Formulary, Japan Pharmacopoeia, British Pharmacopoeia, European Pharmacopoeia, International Pharmacopoeia

Official References:

China Pharmacopoeia, India Pharmacopoeia, Philippine Pharmacopoeia

Unofficial References:

Lititz Pharmacopoeia

The first americal pharmacopeia was called:

1778

• What year was the first american pharmacopoeia published?

January 6, 1817

• Dr. Lyman Spalding, a physician from New york city, submitted a plan to the Medical Society of the Country of New York for creation of national pharmacopoeia

Dr. Spalding

• “Father of United States Pharmacopoeia”

January 1, 1820

• conducted the first United States Pharmacopeia Convention assembled in Washington, D.C.

United States Pharmacopeia - National Formulary

• is a book of public pharmacopeial standards

• it contains standards for medicines, dosage forms, drug substances, excipients, medical devices, and dietary supplements

Monographs

• articulate the quality expectations for a medicine including for its identity, strength, purity, and performace

• they also describe the tests to validate that a medicine and its ingredients meet these criteria.

Chemical Structure,Chemical Name, Purity Rubric, Packaging and storage, Reference Standards, Identification tests, Corresponding tests for chemical and physical constants, water content, assay procedure

• The complete Monograph of a raw material or finished dosage form includes the following information:

General Chapters

• provide broadly applicable information to industry on accepted processes, tests and methods to support product development and manufacturing for innovative, generic and biosimilar medicines.

Defects

• is an undesirable characteristic of a product

• defined as a failure to conform to specifications

Defective

• a unit of product which contains one or more defects is called:

According to measurability, seriousness or gravity, and nature

Classfication of defects:

Variable Defect

• a defect that can be measured directly by instruments

Attribute defect

• cannot be measured by instruments, can be applied on the things that can be judged only by odor, visual examination like color, clarity, cleanliness, smoothness and taste

Variable and Attribute Defect

Defects according to measurability:

Critical defect, major defect, minor defect

According to seriousness or gravity:

Critical defect

• defect which may endanger the life or property and may render the product non functional

Major defect

• defect which may affect the fucntion of the object, may render the product useless

Minor defect

• defect which not endanger the life or property nor will it affect the function but remains a defect outside the prescrbed limits

Ocular defect, internal defect, performance defect

According to Nature:

Ocular defect

• defect that is visible

Internal defect

• defect which not seen although present

Performance defect

• defect in function

Recall

• is the method of withdrawing or correcting unsafe or hazardous health products from the distribution chain that amy present a health hazard to consumer or user

Class 1 Recall

• a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death

Class 2 Recall

• a situation in which of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Class 3 recall

• a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences

Materials

• variation between suppliers of same substance

• variation between batches from same supplier

• variation between the batch

Machines

• variation of equipment for the same process

• difference in adjustment of equipment

• aging and improper care

Methods

• inexact procedures

• inadequate procedures

• negligence by chance

Men

• improper working conditions

• inadequate training, and understanding

• dishonesty, fatigue and carelessness