PHARMACY (MEDICINE )

  1-Click link to Learn Operation of HPLC SHIMADZU  https://youtu.be/bdScAiilTys

                                                                                                                    Qualification and Validation 1- In accordance with GMP, each pharmaceutical company should identify what qualification and validation work is required to demonstrate that it is critical aspects of their particular operation are controlled. 2- Key elements of the company's qualification and validation program should be clearly defined and documented in the master validation plan. 3- Qualification and validation should create and provide documentation proof that: a) Premises, support services, equipment and processes were available designed in accordance with GMP requirements (design certificate, or DQ); b) Premises, supporting engineering networks and equipment were built installed in accordance with their design specifications (installation qualification or IQ); c) The premises, support facilities and equipment functioned in accordance with their design sp

                                                               Dissolution Apparatus 1.0 PURPOSE: 1.1 It is intended to provide a procedure for the operation of a dissolution Apparatus. 2.0 SCOPE: 2.1 Applies to the chemical section of the quality control department 3.0 LIABILITY : 3.1 Q.C. The analyst is responsible for performing the exact operation. 3.2 Q.C. Manager to ensure accurate operation. 4.0 ABBREVIATIONS : 4.1 Quality Control Q.C 4.2 RPM: revolutions per minute 5.0 INSTRUMENT : 5.1 Dissolution Apparatus 6.0 SAFETY PRECAUTIONS: 6.1 Before turning on the heater switch, make sure that the tank is filled with purified water without a container up to the device mark. 6.2 Do not overtighten the paddle/basket and also do not hold the paddle/basket while it is in operation. 6.3 Place the device as far as possible from strong magnetic or electric fields. 6.4 Avoid strong vibration or sunlight. 6.5 Protect the device from dust and corrosive gases 6

  KNAUER HPLC 1. PURPOSE 1.1. It is intended to provide a procedure for the operation of the  HPLC. 2. SCOPE 2.1. It applies to the Azura HPLC present in the quality control department. 3. LIABILITY 3.1. It is the responsibility of the QC Analyst to follow this SOP as written. 3.2. It is the responsibility of the Quality Control Manager to review and update this SOP as necessary and to ensure that this is done 4. ABBREVIATION 4.1. SOP: Standard Operating Procedure 4.2. QC: Quality control 4.3. HPLC: High-Performance Liquid Chromatography 5. SAFETY PRECAUTIONS 5.1. Check all switches. 5.2. Ensure that the operating temperature (25 - 30 C) and humidity (50 - 5%) conditions are observed. 5.3. The UPS is working properly and in good order. 5.4. Make sure all connections are through the UPS and all connecting wires are unbroken. 5.5. Make sure the mobile phase container is connected before turning the switch "ON". 5.6. The knob on the sample injection port should be in the fill po

                    HPLC WORKING PRINCIPLE HPLC stands for High-Performance Liquid Chromatography, and it is a widely used analytical technique in the field of chemistry. The principle behind HPLC is based on the separation of chemical compounds in a mixture using a stationary phase and a mobile phase. The stationary phase is a material that is packed into a column, typically made of stainless steel, and coated with a thin layer of a specific material. The mobile phase is a liquid that is pumped through the column under high pressure, and it contains a mixture of compounds to be separated. As the mobile phase flows through the column, the individual compounds in the mixture interact differently with the stationary phase, based on their chemical properties such as polarity, size, and charge. This results in differential rates of migration, causing the compounds to separate from each other as they move through the column. As each compound exits the column, it is detected by a dete

                                          MEDICINES AND THEIR SIDE EFFECTS Many different types of medicines that can have side effects. Here are some examples of common medicines and their potential side effects: 1.       Pain Relievers: Non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and aspirin can cause stomach ulcers, bleeding, and kidney problems. Acetaminophen (paracetamol) can cause liver damage if taken in high doses. 2.      Antibiotics : Antibiotics can cause allergic reactions, nausea, diarrhea, and in some cases, life-threatening conditions like C. difficile infection. 3.      Antidepressants : Antidepressants can cause dry mouth, dizziness, weight gain, sexual dysfunction, and in rare cases, suicidal thoughts. 4.      Blood Pressure Medications: Some blood pressure medications can cause dizziness, headaches, and kidney problems. 5.      Cholesterol-Lowering Medications: Cholesterol-lowering medications can cause muscle pain and weakness, liver p

GOOD MANUFACTURING PRACTICES FOR PHARMACEUTICAL PRODUCTS Good manufacturing practices (GMPs) are a component of quality assurance that assures products are continuously produced and controlled to the quality standards relevant to their intended use and as required by the marketing authorization.   GMP's main goal is to reduce the risks that come with producing any kind of pharmaceutical. These   risks are of Two types  : (          (1)   cross-contamination (especially with unanticipated pollutants) and            (2)     mix-ups (confusion) brought on, for instance, by the application of misleading labels on containers.  Under GMP: - All manufacturing procedures are thoroughly defined, evaluated in light of experience, and demonstrated to be capable of producing pharmaceutical products consistently that are of the appropriate quality and conform to their specifications.   -Qualification and validation are carried out.   -Essential resources are offered, including:

  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 descriptions for managers clearly define managerial responsibilities. ·        

   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

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, color, dimension, weight, thickness, hardness,  disintegration time, etc are in compliance with the product's specifications at the beginning of the compression run. ·        Check that the process is being followed by the   SOP. ·        Ch

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                                                                      ↓                       becomes an active ingredient                                                  ↓                              pharmacological activity                                                  ↓               diagnosis, cure, mitigation, treatment, or