Quality Assurances SOPs List

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Quality Assurances SOPs List SNo. SOP Title 01 SOP on validation master plan 02 SOP on Function of quality assurance department 03 SOP on periodic physical observation of control sample 04 SOP on job responsibility of personnel working in quality assurance. 05 SOP on in-process sampling and analysis of oral drug products. 06 SOP on … Read more

PROBLEMS AND REMEDIES FOR TABLET COATING

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PROBLEMS AND REMEDIES FOR TABLET COATING Blistering It is local detachment of film from the substrate forming blister. Reason: Entrapment of gases in or underneath the film due to overheating either during spraying or at the end of the coating run. Cause and Remedy of Blistering: Cause: Effect of temperature on the strength, elasticity and … Read more

VALIDATION AND QUALIFICATION OF WATER PURIFICATION,STORAGE,AND DISTRIBUTION SYSTEMS AS PER USP

Purified Water Establishing the Quality of pharmaceutical water purification,storage,and distribution systems requires an appropriate period of monitoring and observation. However, it is more difficult to meet established microbiological quality criteria consistently. A typical monitoring and observation program involves intensive daily sampling and testing of major process points for at least one month after operational criteria … Read more

VITAMINS AND MINERALS CHART

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VITAMINS AND MINERALS CHART Different types of vitamins and minerals enable healthy body function, such as cell and tissue repair, production of cells, and healthy brain function. Your body doesn’t produce these vitamins and minerals on its own, and while you can get most of these from a supplement, your body reacts better when these … Read more

Design Qualification of Gelatin Storage Vessel

Design Qualification of Gelatin Storage Vessel OBJECTIVE: To design, engineer and supply the Gelatin Storage Vessel and to provide assurance that the machine is manufactured and it complies with the Scope of Supply. To prove that each operation proceeds as per the design qualification and the tolerances prescribed there in the document, are the same … Read more

Lubricants and Glidants used in Tablet Formulations

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Tablets Lubricants Lubricants and Glidants used in Tablet Formulations are: • Magnesium stearate • Stearic acid • Sodium stearyl fumarate • Hydrogenated vegetable oil • PEG 4000, 6000 • Hexagonal boron nitride • DL-Leucine • Sodium lauryl sulfate • Gliceryl behenate • Sodium benzoate • Colloidal silicone dioxide • Talc • Starch • Super disintegrants … Read more

Pharmaguidances Whats App Groups

Pharmaguidances Whats App Groups Pharmaguidances   Pharma Post and Jabs     Pharma Vacancy Pharma Post and Jabs 2   Pharmaguideline   Pharmaguideline 2           MFR of SALBUTAMOL SULPHATE TABLET

Preformulation stability studies

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Stability Analysis Preformulation stability studies are the first quantitative assessment of chemical stability of a new drug. This may involve 1. Stability study in toxicology formulation 2. Stability study in solution state 3. Stability study in solid state. Stability Study in Toxicology Formulation: A new drug is administered to animals through oral route either by … Read more

Powder Particle Size Determination Methods for tablets

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Particle Size Determination Methods: 1. Sieving 2. Microscopy 3. Sedimentation rate method 4. Light energy diffraction 5. Laser holography 6. Cascade impaction 1. Sieving method: • Range: 50 – 150 μm • Simple, inexpensive • If powder is not dry, the apertures get clogged. 2. Microscopy: • Range: 0.2 – 100 μm • Particle size … Read more

Powder flow properties in Pharmaceuticals

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Powder flow properties in Pharmaceuticals Apparent bulk density (g/cm3): Bulk drug powder is sieved through 40 mesh screen. Weight is taken and poured into a graduated cylinder via a large funnel. The volume is called bulk volume. Apparent bulk density = Weight of the powder/Bulk volume Tapped density (g/cm3): Bulk powder is sieved through 40 … Read more

TABLET TOOLING

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TABLET TOOLING Basics of Tablet Tooling Tablet compression machines are made keeping in view the type of dies and punches will be used on them. The dies and punches and their setup on compression machine is called tooling, it is classified as B and D mainly. The B tooling dies and punch can further have … Read more

Preformulation for Tablets, Capsules, Liquid Orals

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Preformulation for Tablets, Capsules, Liquid Orals Before developing a formulation like tablets, capsules, liquid orals we study the suitability of new drug or drug and excipients for the chosen formulation which is called preformulation. Preformulation Definition Preformulation may be defined as a stage of the research and development process where the preformulation scientist characterizes the … Read more

Pharmaceutical Quality Assurance -Drug and Therapeutics Committee Training Course

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Pharmaceutical Quality Assurance -Drug and Therapeutics Committee Training Course CONTENTS Pharmaceutical Quality Assurance Acknowledgment Purpose and Content Objectives Outline Key Definitions Introduction Determinants or Aspects of Medicine Quality Critical Elements of a Comprehensive Quality Assurance Program How Is Quality Assessed? How Is Quality Assured? Who Ensures Medicine Quality? Pharmaceutical Quality Assurance—Implications for the DTC Providing … Read more

MONOGRAPH ON LIQUID PREPARATIONS FOR ORAL USE AS PER INTERNATIONAL PHARMACOPOEIA

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MONOGRAPH ON LIQUID PREPARATIONS FOR ORAL USE AS PER INTERNATIONAL PHARMACOPOEIA Definition Liquid preparations for oral use are usually solutions, emulsions or suspensions containing one or more active ingredients in a suitable vehicle, they may in some cases consist simply of a liquid active ingredient used as such. Liquid preparations for oral use are either … Read more

SOP on Testing Efficacy of Disinfectants

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SOP on Testing Efficacy of Disinfectants. Objective: To lay down a procedure for testing efficacy of Disinfectants. Scope : This SOP is applicable for testing of efficacy of disinfectant solutions used in  microbiology laboratory and production area. Responsibility Microbiologist Head-Microbiology Accountability Head-Quality Control Head-Quality Assurance Procedure Prepare Culture suspension of Escherichia coli ATCC 8739, Candida … Read more

Lorazepam Aristo 2.5 mg tablets

Lorazepam Aristo 2.5 mg tablets Active ingredient – lorazepam Legal Category : POM: Prescription only medicine 1. Name of the medicinal product Lorazepam Aristo 2.5 mg tablets 2. Qualitative and quantitative composition One tablet contains 2.5 mg lorazepam. Excipients with known effect Each tablet contains 116.7 mg lactose (as lactose monohydrate). For the full list … Read more

Aciclovir 400 mg Tablets

Aciclovir 400 mg Tablets Active ingredient – Aciclovir Legal Category -POM: Prescription only medicine 1. Name of the medicinal product Aciclovir 400 mg Tablets 2. Qualitative and quantitative composition Each 400 mg tablet contains 400 mg aciclovir. For the full list of excipients, see section 6.1 3. Pharmaceutical form Tablet White to off-white, round (diameter: … Read more

Furosemide 40 mg Tablets

Furosemide 40 mg Tablets Active ingredient – Furosemide Legal Category – POM: Prescription only medicine 1. Name of the medicinal product Furosemide 40mg Tablets 2. Qualitative and quantitative composition Each tablet contains Furosemide 40mg. For a full list of excipients, see section 6.1. 3. Pharmaceutical form Tablet White to off white, flat, uncoated tablets with beveled … Read more

SCHEDULE H1 ( DRUGS AND COSMETICS ACT 1940 AND RULES 1945)

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SCHEDULE H1 ( DRUGS AND COSMETICS ACT 1940 AND RULES 1945) 1.Alprazolam 2.Balofloxacin 3.Buprenorphine 4.Capreomycin 5.Cefdinir 6.Cefditoren 7.Cefepime 8.Cefetamet 9.Cefixime 10.Cefoperazone 11.Cefotaxime 12.Cefpirome 13Cefpodoxime 14.Ceftazidime 15.Ceftibuten 16.Ceftizoxime 17.Ceftriaxone 18.Chlorodiazepoxide 19.Clofazimine 20.Codeine 21.Cycloserine 22.Diazepam 23.Diphenoxylate 24.Doripenam 25.Ertapenem 26.Ethambutol Hydrochloride 27.Ethionamide 28.Feropenam 29.Gemifloxacin 30.Imipenem 31.Isoniazide 32.Levofloxacin 33.Meropenem 34.Midazolam 36.Moxifloxacin 37.Nitrazepam 38.Pentazocine 39.Prulifloxacin 40.Pyrazinamide 41.Rifabutin 42.Rifampicin 43.Sodium Para-aminosalicylate … Read more

SCHEDULE – H (PRESCRIPTION DRUGS) – (THE DRUGS AND COSMETICS ACT 1940 AND RULES 1945 )

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SCHEDULE – H (PRESCRIPTION DRUGS) – (THE DRUGS AND COSMETICS ACT 1940 AND RULES 1945 ) Abacavir Abciximab Acamprosate calcium Acebutol hydrochloride Aclarubicin Albendazole Alclometasone dipropionate Actilyse Acyclovir Adenosine Adrenocorticotrophic hormone (acth) Alendronate sodium Alopurinol Alphachymotrypsin Alprazolam Alprostadil Amantadine hydrochloride Amifostine Amikacin sulphate Amiloride hydrochloride Amineptine Aminoglutethimide Amino salicylic acid Amiodarone hydrochloride Amitriptyline Amlodipine besylate … Read more