TIPS TO MANAGE MENTAL HEALTH
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02- IN-PROCESS CHECKS OF GRANULATION/MIXING (PHARMACEUTICALS)
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), granulator, fluidized bed dryer, cone mixer, and other utensils are properly cleaned. Check that the HVAC system is working properly and note Temp/Humidity. Check that all personnel is wearing protective garments properly. Check that the physical characteristics of raw materials like odor, color,
01-SOP FOR IN PROCESS CHECKS DURING MANUFACTURING AND PACKING (PHARMACEUTICAL)
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 especially at the time of start of a new batch or product, on same line in-process check will be carried out. · Ensure that the packing belt, packing hall, filling machines, conveyor belts and overprinting area is clean and clear. · Review the
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TOP 10 BENEFITS TO USING TURMERIC FOR YOUR HEALTH
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 suffer from dementia and also Alzheimer's. 5- Curcumin can actually lead to decreased risk of heart disease we know that c
PARACETAMOL (ACETAMINOPHEN) TOXICITY , SPECIFIC INGESTION & TREATMENT :
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 Postingestion): Nausea, Vomiting, Anorexia, and Diaphoresis 2 - Phase II (1to 4 days Postingestion): Asymptomatic 3- Phase III (2 to 3days in untreated patients): Nausea, Abdominal pain, Progressive evidence of Hepatic failure, coma, and Death. Laboratory Data: A- Serum Acetaminophen Levels B- Baseline LFT C- RFT (BUN, SCr) D- Coagulation study (PT,
01-SOP FOR IN PROCESS CHECKS DURING MANUFACTURING AND PACKING (PHARMACEUTICAL)
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 especially at the time of start of a new batch or product, on same line in-process check will be carried out. · Ensure that the packing belt, packing hall, filling machines, conveyor belts and overprinting area is clean and clear. · Review the
TIPS TO MANAGE MENTAL HEALTH
QUALITY MANAGEMENT IN THE DRUG INDUSTRY
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
THEOPHYLLINE TOXICITY, SPECIFIC INGESTION & TREATMENT :
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- Theophylline levels: 5 to 20µg/ml B- Hyperglycemia and Hypoglycemi a: after acute ingestion C- Other tests include: Serum Electrolytes, BUN, Creatinine, Hepatic Function, ECG Monitoring Treatment: 1-Supportive Therapy: · Maintaining airway · seizures Treatment · Dysrhythmia Treatment
HPLC WORKING PRINCIPLE
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
Active pharmaceutical ingredient (API)
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
QUALITY ASSURANCE
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. ·
HPLC CALIBRATION SOP
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 CHARACTERISTICS 1. Accuracy 2. Precision 3. Specificity 4. Detection Limit 5. Quantitation Limit 6. Linearity 7. Range 1- ACCURACY Definition The closeness of test results obtained by that method to the true value. The accuracy of an analytical method should b