analysis 1

• Pharmaceutical Analysis - a branch of chemistry, which involves the series of process for the identification, determination, quantitation, and purification.
• Pharmaceutical Analysis - used for the separation of the components from the mixture and for the determination of the structure of the compounds.
• The different pharmaceutical agents are as follows:

  1. Plants 2. Microorganisms

  3. Minerals

  4. Synthetic compounds
• Qualitative analysis: This method is used for the identification of the chemical compounds.
• Quantitative analysis: This method is used for the determination of the amount of the sample.
• Quantitative Pharmaceutical Chemistry

  • Defined as the application of the procedures of quantitative analytical chemistry to the:

  1) Analysis and determination of the purity and quality of drugs and chemicals used in pharmacy especially those official in USP and NF;

   

  2) Analysis of the chemical constituents found in the human body whose altered concentrations during disease states serve as diagnostic aids in the practice of medicine;

   

  3) Analysis of medicinal agents and their metabolites found in biological systems.
• REPUBLIC ACT No. 10918

  • An Act Regulating and Modernizing the Practice of Pharmacy in the Philippines, Repealing for the Purpose Republic Act Numbered Five Thousand Nine Hundred Twenty-One (R.A. No. 5921), Otherwise Known as the Pharmacy Law.
• Republic Act No. 10918

  Section 1. Title. - This Act shall be known as the "Philippine Pharmacy Act".
• Responsibility for Quality of Pharmaceutical Products:

  • Pharmacists must ensure that all pharmaceutical products meet safety, quality, and efficacy standards
  • Owners, managers, or pharmacists in charge of pharmaceutical establishments are jointly responsible for nonconformance with standards
• It is illegal to:

  • Manufacture, prepare, sell, or dispense pharmaceutical products under a fraudulent name or pretense
  • Adulterate any pharmaceutical product offered for sale
• Liability for pharmaceutical products sold in their original package, with an unbroken seal, rests upon:

  • The manufacturer or importer
  • The distributor, representative, or dealer responsible for distribution or sale
• Good Laboratory Practice is a quality system concerned with the organizational process and the conditions under which a study is planned, performed, monitored, recorded, archived and reported.
• Why GLP?

  • Development of quality test data

  • Mutual acceptance of data

  • Avoid duplication of data

  • Avoid technical barriers to trade

  • Protection of human health and the environment
• Scope of GLP

  • Non-clinical safety testing of test items contained in

  • Pharmaceutical products

  • Pesticide products

  • Cosmetic products

  • Veterinary drugs

  • Food and feed additives

  • Industrial chemicals
• CURRENT GOOD MANUFACTURING PRACTICE

  • The methods used in, or the facilities or controls used for, the manufacture, processing, packing or holding of a drug conform to or are operated or administered in conformity with current good manufacturing practice to assure that a drug meets the requirements of the act as to safety, and has the identify and strength and meets the quality and purity characteristics which it purports or is represented to possess, as required by section 18 (a) of the Food, Drug and Cosmetic Act (Republic Act 3720).
• Republic Act 3720 -  Food, Drug and Cosmetic Act
• CURRENT GOOD MANUFACTURING PRACTICE

  • The regulations that permit the use of precision automatic, mechanical, or electronic equipment in the production and control of drugs when adequate inspection and checking procedures are used to assure proper performance.
• • Good Manufacturing Practice (GMP) - is the part of Quality Assurance that ensures that products are produced and controlled consistently and reliably. This consistency of production and control is essential. It can only come about by having clear descriptions of the way in which the work will be done.
• Ø GMP - specifically addresses risks of cross-contamination and mix-up that cannot be fully controlled by testing of the final product.
• OBJECTIVES OF GMP

  Ø To understand key elements in quality control.

   

  Ø To understand specific requirements on organization, procedures, processes and resources.
• Ø These risks can best be controlled by having a properly managed system of working that takes them into account. This means that the quality checking system must be designed with these risks in mind and set out to find whether any errors have occurred.
• Objectives of QC:

  • Provide assurance that products will be consistently of a quality appropriate for their intended use.

   

  • To assure that all quality control arrangement are in place and in fact carried out.
• Quality Control

  • System appropriate to the manufacture of pharmaceuticals.

   

  • Mandatory involvement of personnel in the entire product processing and distribution.

   

  • Independent unit with competent staff, adequate and suitable equipment and facilities

   

  • Compliance to GLP
• o Quality control involved sampling, inspecting and testing of starting materials, in process, intermediate, bulk and finished products.
• Quality Control also includes where applicable, environment monitoring program, review of batch documentation, sample retention programs, stability studies and maintaining correct specification of materials and products.