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LIMON, JONALYN RIVO 18-4807-186

BS PHARMACY 1ST YR DEC. 18,2018

PHARMACOPOEIA

 A pharmacopoeia is a legally binding collection of standards and quality specifications for


medicines used in a country or region. Within the pharmacopoeia, a quality specification is a set
of appropriate tests that will confirm the identity and purity of the product, ascertain the strength
(or amount) of the active substance and, when needed, the performance characteristics.
Reference substances are used in testing to help ensure the quality, such as identity, strength and
purity, of medicines.
 A pharmacopoeia also covers pharmaceutical starting materials, excipients, intermediates and
finished pharmaceutical products (FPPs). General requirements may also be given on important
subjects related to medicines quality, such as analytical methods, microbiological purity,
dissolution testing, or stability

QUALITY CONTROL/ QUALITY ASSURANCE

 Quality control (QC) is a procedure or set of procedures intended to ensure that a manufactured
product or performed service adheres to a defined set of quality criteria or meets the
requirements of the client or customer.

 QC is similar to, but not identical with, quality assurance (QA). QA is defined as a procedure or set
of procedures intended to ensure that a product or service under development (before work is
complete, as opposed to afterwards) meets specified requirements. QA is sometimes expressed
together with QC as a single expression, quality assurance and control (QA/QC).

 In order to implement an effective QC program, an enterprise must first decide which specific
standards the product or service must meet. Then the extent of QC actions must be determined
(for example, the percentage of units to be tested from each lot). Next, real-world data must be
collected (for example, the percentage of units that fail) and the results reported to management
personnel. After this, corrective action must be decided upon and taken (for example, defective
units must be repaired or rejected and poor service repeated at no charge until the customer is
satisfied). If too many unit failures or instances of poor service occur, a plan must be devised to
improve the production or service process and then that plan must be put into action. Finally, the
QC process must be ongoing to ensure that remedial efforts, if required, have produced
satisfactory results and to immediately detect recurrences or new instances of trouble.
LIMON, JONALYN RIVO 18-4807-186
BS PHARMACY 1ST YR DEC. 18,2018

Pharmaceutical analytical techniques explain the process or different processes to identify and
quantify a substance, the components of a pharmaceutical solution or mixture or the determination of
the structures of chemical compounds used in manufacturing of the pharmaceutical product. The
components monitored include process impurities, chiral or achiral drugs, residual solvents, degradation
products, excipients such as preservatives, extractable and leachable from container and closure or
manufacturing process, pesticide in drug product from plant origin, and metabolites.

ANALYTICAL METHODS OF ANALYSIS

 Analytical chemistry studies and uses instruments and methods used to separate, identify, and
quantify matter. In practice, separation, identification or quantification may constitute the entire
analysis or be combined with another method. Separation isolates analytes. Qualitative analysis
identifies analytes, while quantitative analysis determines the numerical amount or
concentration.
 Analytical chemistry consists of classical, wet chemical methods and modern, instrumental
methods.[2] Classical qualitative methods use separations such as precipitation, extraction, and
distillation. Identification may be based on differences in color, odor, melting point, boiling point,
radioactivity or reactivity. Classical quantitative analysis uses mass or volume changes to quantify
amount. Instrumental methods may be used to separate samples using chromatography,
electrophoresis or field flow fractionation. Then qualitative and quantitative analysis can be
performed, often with the same instrument and may use light interaction, heat interaction,
electric fields or magnetic fields. Often the same instrument can separate, identify and quantify
an analyte.

ANALYTICAL METHOD OF VALIDATION

Method validation is the process used to confirm that the analytical procedure employed for a specific
test is suitable for its intended use. Results from method validation can be used to judge the quality,
reliability and consistency of analytical results; it is an integral part of any good analytical practice.
Analytical methods need to be validated or revalidated

 before their introduction into routine use;


 whenever the conditions change for which the method has been validated (e.g., an instrument
with different characteristics or samples with a different matrix); and
 Whenever the method is changed and the change is outside the original scope of the method.
LIMON, JONALYN RIVO 18-4807-186
BS PHARMACY 1ST YR DEC. 18,2018

REFERENCES:

https://whatis.techtarget.com/definition/quality-control-QC

https://pharma-medicinalchemistry.conferenceseries.com/events-list/pharmaceutical-analysis-analytical-methods

http://www.labcompliance.com/tutorial/methods/default.aspx
LIMON, JONALYN RIVO 18-4807-186
BS PHARMACY 1ST YR DEC. 18,2018