SANTA LUCIA HIGHER TECHNOLOGICAL INSTITUTE

PROFESSIONAL CAREER IN PHARMACY TECHNICIAN

MODULE QUALITY CONTROL TECHNIQUES

QUALITY CONTROL TECHNIQUES

EN LÍQUIDOS
TEACHER SAVADOR ROMERO

SEMESTER VI SEMESTER

STUDENT :

Rocío Canchihuamán Suasnabar

ARZAPALO HUAMÁN HEYDY

TARM PERU

2016
 INTRODUCTION

The purpose of this work is to explain quality control in

liquid drugs. Currently, control is being developed in the pharmaceutical industry.

of quality the quality of the drugs in such a way that they comply with the

expected characteristics to meet consumer needs: identity,

purity, power

The control of how it is applied in the pharmaceutical industry is the organized effort

in designing, maintaining, and ensuring the quality of each of the drugs that

elaborate. This effort is aimed at achieving the quality of the medication,

verify its excellence step by step and reproducibility batch by batch.

In the pursuit of achieving total dominance through quality, the process of

validation that consists of establishing the documented evidence that demonstrates

a high degree of reliability.

Validation aims to achieve a total mastery of quality. It does not increase the

quality, but increases reliability and unity.

 QUALITY CONTROL

It consists of taking measurements of product parameters, determining

if the obtained values are in accordance with specifications

pre-established. Generally, this quality control is applied to the

products produced and used by a company, whether they are products

final goods, intermediaries or raw materials.

QUALITY CONTROL DEPARTMENT

Every entity that has a manufacturing authorization must have a

Quality Control Department The independence of the department of

production and other departments is considered fundamental Under the

authority of a properly qualified person with experience of one or

several control laboratories at your disposal.

BASIC REQUIREMENTS FOR QUALITY CONTROL

Resources

Adequate physical facilities

Skilled personnel

Approved procedures

BASIC REQUIREMENTS FOR QUALITY CONTROL

Tasks
 Sampling

Preparation of work patterns

Inspection

Essays

Surveillance

Release/refusal

BASIC REQUIREMENTS FOR QUALITY CONTROL

Objects

Raw material

Packaging materials

Intermediate products

Bulk products

Finished products

Environmental conditions

BASIC REQUIREMENTS FOR QUALITY CONTROL

Sampling approved by the CC department

2. Validated analysis methods

3. Records

4. Review and production of production documentation

5. Investigations of the failures for all deviations

6. Ingredients that comply with the marketing authorization

7. Ingredients that have the required purity

8. Suitable containers

9. Correct labeling

10. Release of the batches by the authorized person

11. Retention samples of raw materials and products

Pharmaceutical controls

Routine tests in quality control

The analytics conducted in a Control Department

Quality is numerous and varied, due to the large number of

different products that are analyzed and the requirements of each

product.

Some tests are specific to certain products while

What other essays are more general and are conducted for almost everyone?

the products.

PHARMACEUTICAL CONTROLS

Routine tests in quality control

Aspect

It is about making a qualitative description of the product, whether it is

raw material as finished or intermediate product. They are verified.

different product characteristics such as: appearance (solid,

liquid, suspension...), color, shape, size, etc.

Identification

The identification tests must establish the identity of the product.

analyzed and capable of distinguishing between similar compounds or of

related structure that can be part of the sample. This essay

it must be as specific as possible. The lack of specificity of a method

identification can be resolved by combining several

methods

PHARMACEUTICAL CONTROLS

USUAL TESTS IN QUALITY CONTROL

Content essay

It consists of a quantitative determination of the product, to establish its

degree of purity or to determine the content of one or more

components

Related substances
Under this name, possible impurities that a can contain are collected.

shows both derivatives of the degradation of some of the components

from the sample as well as from the production process

PHYSICAL-CHEMICAL PROPERTIES

The properties to be determined vary depending on the nature of the

product. In liquid preparations pH, acidity,...in solids size of

particle, hardness, etc.

PHARMACEUTICAL CONTROLS IN LIQUIDS

BIOLOGICAL ESSAYS

These types of tests are conducted using microbiological organisms to

evaluate certain properties of the drug. They are usually conducted to

liquid samples of which their sterility or load must be evaluated

microbiological, or for antibiotics and vaccines to determine their

effectiveness

PHARMACEUTICAL CONTROLS

INSTRUMENTAL METHODS

High-Performance Liquid Chromatography

Application in: content assays, characterization of impurities

(coupled with mass spectrometry), determination of impurities and

stability tests
Gas chromatography

Aplicación en: ensayos de contenido, caracterización de impurezas

(coupled with mass spectrometry), determination of impurities and

determination of volatile organic impurities (residual solvents)

UV-Visible Spectrophotometry

Application in: content essays, dissolution essays, and determination

of impurities

Infrared Spectrophotometry

Application in: identification tests

Near-infrared spectroscopy

Application in: ongoing trials Absorption spectrophotometry/

atomic emission Application in: metal content testing (Na, Li, K)

and determination of metallic impurities (Fe, Al,…).

Polarimetry

Application in: determination of optical purity and determination of excesses

enantiomeric

PHARMACEUTICAL CONTROLS

New instrumental methods

Thermal analysis methods

Differential Scanning Calorimetry (DSC) Thermogravimetry (TG)

CAPILLARY ELECTROPHORESIS

Trend to replace High-Performance Liquid Chromatography

VALIDATION OF ANALYSIS METHODS

The analysis methods used in quality control of

Pharmaceutical products must have been validated prior to their use.

in routine.

The validation of a testing method aims to demonstrate

the suitability of that method for conducting an analysis

determined.

Through the validation of a method, it is determined whether the parameters

of quality meet the requirements of an analytical application

concrete.

Experimentation and comparison with reference values are required.

well known.

QUALITY CONTROL OF PHARMACEUTICAL LIQUIDS

CHECK

LABELING
1.1 Trade Name and Generic Name

1.2 Sanitary Registration Number

1.3 Manufacturer laboratory and holder of the registration

1.4 Lot number

1.5 Expiration date

1.6 Pharmaceutical form

1.7 Product formulation

1.8 Labeled volume of the product

1.9 drops contained in one milliliter when required

1.10 Storage conditions when required

1.11 Route of administration (I.M., I.V., subcutaneous, intravenous infusion, and

others)

1.12 Contraindications

1.13 Legend sale under medical or dental prescription or over-the-counter sale according to

the case

1.14 Maximum retail price.

1.15 Legend 'keep out of reach of children'

On the labels and tags of the packaging, which due to their characteristics do not

they can carry the established information, they must declare at least the

nombre del producto, formulación del producto, número de registro sanitario,

batch number, expiration date and route of administration.

2. DESCRIPTION OF THE TYPE OF PACKAGING

2.1 Type of packaging

2.2 Type of closure

2.3 Type of secondary packaging

3. PHYSICAL AND PHYSICAL-CHEMICAL TESTS

3.1 Hermeticity of the closure

3.2 Organoleptic characteristics (appearance, color, smell, and others)

3.3 Volume and volume variation

3.4 Strange particles

3.5 pH

3.6 Clarity (solutions)

3.7 Uniformity and particle size (suspensions and emulsions)

3.8 Redispersion (suspensions)

3.9 Densidad
3.10 Qualitative analysis of active ingredient(s)

3.11 Quantitative analysis of active ingredient(s)

3.12 Degradation products (if required)

3.13 Related substances (if required)

3.14 Impurities (if required)

Biological Essays

4.1. Sterility

4.2. Pyrogens

4.3. Biological assessment (if required)

4.4. Toxicity or safety (if required

4.5. Endotoxin limit (if required)

4.6. Effectiveness of the antimicrobial agent (if required)

QUALITY CONTROL

CHECK

CLIP

Metallic exterior device that guarantees the closure and insulation of a

product.
SECURITY BAND

Supplement incorporated into the closure of the packaging (primary and/or secondary) for

prevent product adulteration.

BIOAVAILABILITY

It is a term that implies the measurement of speed and total quantity.

of the drug that reaches the general circulation from a form

administered dosage.

BIOEQUIVALENCE

It is a term that indicates that a drug is available in two or more forms.

pharmaceuticals show comparable bioavailability.

QUALITY

Set of characteristics of a product that determines its suitability for the

use. In a medication, quality is determined by its characteristics.

of identity, purity, content, potency, stability, safety and

presentation.

CLOSURE

System or device that prevents the content of a container from exiting and is

constitutive part of it.

COMPREHENSIVE QUALITY CONTROL

Set of procedures aimed at verifying the level of quality and the

compliance with the specifications of: raw materials, materials of

packaging, products in process, finished products, areas and

manufacturing and packaging operations, checking their purity, activity,

uniformity, safety, bioavailability, stability over time

shelf life and compliance with GMP.

DEFECT

Any discrepancy or disagreement of the product unit with

regarding its specifications.

CRITICAL DEFECT

It is one that affects the quality of the product, making it unusable,

becoming a risk for the user.

DEFECTO MAYOR

Defect that, while not critical, can alter the quality of the product or reduce it.

considerably its utility.

Minor defect

Defect that does not affect the quality or proper use of the product

DRUG Natural origin product, prepared

and stabilized, capable of being converted into medication.

DOSE

Total amount of medication administered at one time, or total of

fractionated amounts administered over a specified period.

PACKAGING

Product conditioning for transport purposes.

SPECIFICATIONS

Documented description of the requirements that products must meet

or materials used or obtained during manufacturing. The specifications

they serve as a basis for quality assessment.

STABILITY

Capacity of a medication in a specific packaging and sealing system,

to maintain its initial quality characteristics (physical,

chemical, microbiological, therapeutic, and toxicological.

DRUG

It is the active ingredient of a medication, which can be obtained by

synthesis, extraction and/or purification of natural resources.

EXPIRATION DATE
It is the time limit until which the product is guaranteed to maintain

the quality characteristics (physical, chemical, microbiological,

therapeutic and toxicological.

PHARMACEUTICAL FORM

Drug delivery system (SENF)

INSPECTION

It is a process that consists of observing, examining, measuring, and comparing the

quality characteristics of the unit under study concerning its

specifications.

LOT

Quantity of a product of homogeneous quality, which is produced in a

same controlled manufacturing cycle and has an identification code

specific.

PACKAGING OR PACKAGING MATERIAL

Material or set of elements that are used to contain, protect and

identify a product. The primary packaging is considered to be the one that is in

direct contact with the product (packaging and closure); the other elements are

consider secondary packaging.

MEDICATION
It is that pharmaceutical preparation that contains active ingredients, with or without

auxiliary substances, presented in a pharmaceutical form, are used for

the prevention, relief, diagnosis, treatment, healing or rehabilitation of

A disease. Containers, labels, tags, and packaging are part of

integral of the medication, as they guarantee its quality, stability

and proper use.

SAMPLE

Statistically representative number of units extracted from a batch,

from which the necessary information is obtained to evaluate one or more of

its characteristics of that batch or its manufacturing process.

Commercial Name

It is the registered name by a commercial firm that identifies a product.

for the purposes of manufacturing, distribution, and sale.

GENERIC NAME

It is the name used to distinguish a product that is not protected.

by a brand of the factory, generally corresponds with the denomination

internationally recommended by the WHO.

LOT NUMBER OR CODE

It is the combination of characters (letters, numbers, etc.) that identify the

units of the same batch.

DEGRADATION PRODUCT

Substances that come from the decomposition of any of the

product components.

DEFECTIVE PRODUCT

The one that has one or more defects.

ALTERED PHARMACEUTICAL PRODUCT.

The one who finds themselves in one of the following situations: When there will be

has undergone transformations in its physicochemical and biological characteristics,

organoleptic, or in their therapeutic value due to chemical agents,

physical or biological. When the expiration date has passed

corresponding to the product's lifespan. When the content does not

corresponds to the authorized or has been taken from the original, total or

partially. When by its nature it is not stored or

preserved with due precautions. When it has been replaced,

totally or partially removed or replaced the constitutive elements that

are part of the officially approved composition or when it is given

they would have added substances that could modify their effects or their

pharmacological, physicochemical, or organoleptic characteristics.

FRAUDULENT PHARMACEUTICAL PRODUCT

He who finds himself in one of the following situations: The one prepared by

pharmaceutical laboratory that does not have a Health License from

Functioning. The one made by a pharmaceutical laboratory that does not have

authorization for its manufacture. The one that does not come from the holder of the Registry

Sanitary, from the pharmaceutical laboratory manufacturer or from the distributor or

authorized vendor, in accordance with the regulations issued for that purpose

the Ministry of Health. Whoever uses packaging, wrapping, or labeling different from

authorized. The introduced into the country without meeting the technical requirements and

legally established in Decree 677/95. With the brand, appearance or

general characteristics of a legitimate and officially approved product,

without being it. When it is not protected by Sanitary Registration.

SANITARY REGISTRATION

It is the public document that empowers a natural or legal person.

to produce, market, import, export, package, process and/or

to dispense medications, cosmetics, pharmaceutical preparations to

natural resource base, cleaning, hygiene, and sanitation products and others

household products.

LABELING

It is a written system used to identify and provide information about a

product

THERAPEUTIC SYSTEM
It is a device that contains one or more drugs programmed to

continuous release, over a fixed period of time. Its action can be

systemic and can be directed to a specific organ.

RELATED SUBSTANCES

They are substances that have a chemical structure similar to that of the principle.

active ingredient of the medication. These substances can be products of

degradation or byproducts of the synthesis, identified or not.

LIFETIME

Time interval during which a medication is expected to

stored correctly, maintain quality specifications

established. The shelf life is determined through stability studies and

it is used to establish the expiration date.

Collapsible Tubes

Cylindrical-shaped container, flexible, plastic or metal with coating

interior that dispenses the product by extrusion.

VALIDATION OF ANALYTICAL METHODS.

Process by which it is established through laboratory studies the

documented evidence that an analysis method meets the requirements

analytical metrics for what has been developed. The parameters

Validation analytics are: accuracy, precision, selectivity, linearity and

linearity interval, detection limit, quantification limit and

robustness.

GENERAL RULES

3.1 STANDARD 01

RECEPTION, CLASSIFICATION AND DISTRIBUTION OF SAMPLES

Objective

The purpose of this standard is to describe the procedure for receipt,

classification and distribution of samples of the products sent by the

Division of Regulation and Monitoring of Health Services and Entities

Competent officials for quality control within the program of

surveillance. RECEIPT All samples must arrive at the laboratory and be

you will receive at the SECRETARY OF THE LABORATORY DIVISION OF

MEDICINES AND BIOLOGICAL PRODUCTS, where will it continue

Next step: The product will be recorded in the registration book, where

it will be recorded: the trade name, the manufacturing lab and holder,

origin, the number of samples, the reason for the shipment, the date of

arrival, the type of analysis requested, the maintenance conditions of the

sample and sample status. The minimum samples required for the

Complete Quality Control analysis includes the following:

PRODUCT QUANTITY
Liquids 30

(suspensions, syrups, solutions, elixirs, and tinctures)

single-dose presentations 120 ml

{"question1":"What is quality in a medication?","question2":"Why is quality important?"}

It means that the medication must comply with technical standards and to the

specifications defined by the manufacturer for its use. Set of

characteristics inherent to a process, a product, or a service, from the

technical and human point of view, to produce the desired effects by the

user. It means that the medications must be manufactured and controlled.

according to a set of 'best practices', that is, norms which, once

obedience leads to the quality of a medication.

The quality of a medication is measured by its ability to exert the effect.

therapeutic that is expected from it. That capacity is determined by the

properties that influence the results, such as their identity, purity,

content or power, the chemical, physical and biological properties or of its

manufacturing process. When used, a medication must: • be able to

act on the health situation/problem for which it was prescribed; •

present acceptable levels of toxicity, that is, that the benefits of its

use should outweigh their risks.

 BIBLIOGRAPHY

-INTERAMERICAN ACTION FOR THE HEALTH. Generics y

bioequivalence: balance and perspectives in Latin America. In: ACCESS

UNIVERSAL AND RATIONAL USE OF MEDICINES, 2004, Lima.

MARCHAND, B. Looking for remedy: basic care and use of

essential medicines: a guide for learning and action for the

local health worker. Managua: Inter-American Action for

Health, 1995.

Amends provisions of the Laws. National Health Surveillance System.