PHARMACY (MEDICINE )

  PARACETAMOL (ACETAMINOPHEN) TOXICITY , SPECIFIC  INGESTION & TREATMENT :                                          Acetaminophen  (Paracetamol) : Def: ·         an antipyretic –analgesic ·         can produce fatal Hepatotoxicity in the untreated patient through toxic metabolite Available dosage forms : ·         Available in a variety of OTC & Prescription drug products. Toxicokinetics: ·         Well  absorbed from GIT ·         Half-life between 2 and 3 hrs. ·         Less than 5% excreted in Urine ·         Remainder metabolized in the liver by Cytochrome P450 Clinical Presentation: 1- Phase I (12 to 24Hrs Po...

    SOP FOR IN PROCESS CHECKS DURING MANUFACTURING AND PACKING  1.                     RESPONSIBILITY AND AUTHORITY:       Quality Assurance manager           Q uality assurance Officer         Packing Pharmacist 4.                PROCEDURE: To carry out effective in-process checking control ensures that the following practices are observed by all the packing / in-process control Pharmacist. ·         The correct uniform, coats and head-dress must be worn at all times. Gloves and mask also be worn whenever a product is being filled into its primary package and is therefore in danger of contamination during packing.   ·         In-process check should be carried out on every packing line after every 30minutes...

                                        Top 10 benefits to using turmeric for your Health 1-It contains bioactive compounds with very powerful medicinal purposes,   it contains something called curcumin which is the antimicrobial,  anti-inflammatory, and antioxidant substance that makes up most of the turmeric.   2- Turmeric is a natural anti-inflammatory curcumin which is in Turmeric has been shown to have natural anti-inflammatory properties so in  particular this has been shown to play a major role in reducing inflammation throughout the body.   3- Turmeric has been shown to increase antioxidant properties within the body this is important to get rid of free radicals inside your body and to release all toxins at your body that might be accruing over time.   4- Curcumin has been linked to improving brain function this is important for people who s...

   QUALITY MANAGEMENT IN THE DRUG INDUSTRY Quality management is typically referred to in the larger pharmaceutical industry as the part of the management function that chooses and puts into practice the "quality policy," or the overall intention and course of an organization about quality, as formally expressed and authorized by top management. The fundamental components of quality management are: 1— an appropriate infrastructure, or "quality system ," encompassing organizational structure, procedures, processes, and resources; 2— systematic actions required to ensure sufficient confidence that a Product ( or service) will meet predetermined standards for quality. Quality assurance refers to the sum of these efforts. The management tool of quality assurance is used within a company. Quality control also helps to build supplier confidence in contractual contexts. Aspects of quality management that are interrelated include the ideas of quality assurance, G...

                                                         HPLC CALIBRATION SOP  PURPOSE: All instruments should be calibrated and the appropriate correction applied to the original measurements.  This calibration system should bring about trust in decisions or measures.  1.1          To check the performance of the instrument.  1.2          To avoid the variation/wrong result 1.3          To achieve the result according to the specification. 2.0        PROCEDURE: VALIDATION: Validation of an analytical method is a process by which it is established, by laboratory studies, that the performance characteristics of the method meet the requirements for the intended analytical applications.   ANALYTICAL PERFORMANCE CHARACTERISTI...

03-   IN-PROCESS CHECKS OF TABLET   COMPRESSION ·        Check the status of the Q.C.'s released label and Report of Bulk in the batch production record file. ·        Check that the ingredients, containers, labels, and documents from preceding batches have been taken out. ·        Check the cleanliness of the ceiling, floor, doors, windows, and other surfaces. ·        Check the dust collector is turned on and operating correctly. ·        Check the HVAC system's functionality. ·        Check that the analytical balance, compression machine, and other tools are correctly cleaned and calibrated. ·        Check that everyone using protective gear is carrying it out correctly. ·        Check the physical characteristics...

  THEOPHYLLINE    TOXICITY, SPECIFIC    INGESTION & TREATMENT : THEOPHYLLINE : Intro of    Drug :         Theophylline occurs in tea and cocoa beans in trace amounts. Available dosage forms :    Liquid sustained-release tabs, caps & parenteral.   Toxicokinetics: ·          Well absorbed Orally  Volume of distribution approx. 0.5L/Kg ·          Hepatically metabolized ·          Clearance depends on age, disease states & interacting drugs. Clinical Presentation: ·        a feeling of loathing   ·          Vomit ·       Convulsion ·          Cardiac Dysrhythmias ·          Chronic toxicity  Laboratory Data: A-  ...

Active pharmaceutical ingredient (API): DEF: Any substance or mixture of substances intended to be used in the manufacture of a pharmaceutical dosage form and that, when so used, becomes an active ingredient of that pharmaceutical dosage form. Such substances are intended to furnish pharmacological activity or another direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.   An Illustration :                       substance or mixture of substances                                                 ↓        manufacture of a pharmaceutical dosage form                                  ...

  QUALITY ASSURANCE Principle :   A broad concept called "Q uality Assurance" encompasses all elements that can have an individual or overall impact on a product's quality. The sum of all the measures made to guarantee that pharmaceutical products are of the quality needed for their intended purpose. Quality  assurance consequently takes into account GMP as well as other elements, such as product development and design, that fall outside the purview of following guide. The system of quality assurance appropriate to the manufacture of pharma [1] ceutical products should ensure that: ·        -  Taking into consideration GMP's requirements as well as those of other related codes, such as good laboratory practice (GLP) and good clinical practice (GCP). ·        -  Written specifications for production and control operations and the adoption of GMP standards. ·        -  Job descriptio...

                                 02- IN-PROCESS CHECKS OF GRANULATION/MIXING                                                                    (PHARMACEUTICAL)   PROCEDURE: Check that Manufacturing Order is signed. Check that all the dispensed raw materials (Active & Inactive) have proper identification and their quantities are correct.   Check that the materials, containers, and identification slips of previous batches have been removed. Check that the process identification slip/label has been pasted. Check the cleaning of walls, windows, lights, doors, ceiling, floor, etc. Check that the mixer (Ribbon/spiral), gr...