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:…
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…
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…
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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…
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Manner of Labelling .— (1) Subject to the other provisions of these Rules, the following particulars shall be either printed or written in indelible ink and shall appear in a conspicuous manner on the label of the innermost container of any drug and on every other covering in which the container is packed, namely :—…
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Personnel Qualification for Aseptic Processing and Sterility Testing Area Objective: To lay down the procedure for Personnel Qualification to enter and work in the Aseptic Processing area and Sterility Testing Area. Scope: This SOP is applicable for Personnel Qualification to work in Aseptic Processing and Sterility testing Area Procedure: For the Aseptic Processing Area The…
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Objective: To lay down the procedure for Personnel Qualification to enter and work in Aseptic Processing area and Sterility Testing Area. Scope: This SOP is applicable for Personnel Qualification to work in Aseptic Processing and Sterility testing Area. Responsibility: Chemist or above of Microbiology Laboratory. Head – Microbiology Section. Accountability: Head – Quality Control Head…
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Objective: To lay down the procedure for Viable Particulate Monitoring of Drain Points – Sterile Product Manufacturing Facility Scope: This SOP is applicable for Viable Particle Monitoring of Drain Points – Sterile Product Manufacturing Facility Responsibility: Officer or above of Microbiology Laboratory. Head – Microbiology section / Nominee. Accountability: Head – Quality Control / Nominee….
Objective: To lay down a procedure for calibration of pH Meter. Scope: This SOP is applicable for calibration of pH Meter in quality control laboratory. Responsibility: Officer or above of QC laboratory is responsible for calibration of pH Meter Head Quality / nominee of QC department is responsible for reviewing and approval of the SOP…
Aceclofenac 100 mg Film-coated Tablets 1. Name of the medicinal product Aceclofenac 100 mg Film-coated Tablets 2. Qualitative and quantitative composition Each film-coated tablet contains 100 mg of aceclofenac For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet. White, round, biconvex film-coated tablets, 8 mm diameter. 4. Clinical particulars 4.1…
Guidance for Industry II. QUESTIONS AND ANSWERS A. Scope (1) 1.1: Should GMP according to ICH Q7 be applied for manufacturing steps before the defined API starting material, i.e., steps not identified in grey in Table 1? ICH Q7 does not apply to steps prior to the introduction of the API starting material. However, there…
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Actelsar HCT tablets 1. Name of the medicinal product Actelsar HCT 40 mg/12.5 mg tablets Actelsar HCT 80 mg/12.5 mg tablets 2. Qualitative and quantitative composition Actelsar HCT 40 mg/12.5 mg tablets Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide. Actelsar HCT 80 mg/12.5 mg tablets Each tablet contains 80 mg telmisartan and…
Actos tablets 1. Name of the medicinal product Actos 15 mg tablets Actos 30 mg tablets Actos 45 mg tablets 2. Qualitative and quantitative composition Actos 15 mg tablets Each tablet contains 15 mg of pioglitazone (as hydrochloride). Excipient with known effect Each tablet contains 92.87 mg of lactose monohydrate (see section 4.4). Actos 30…
ABILIFY 1 mg/mL oral solution 1. Name of the medicinal product ABILIFY 1 mg/mL oral solution 2. Qualitative and quantitative composition Each mL oral solution contains 1 mg of aripiprazole. Excipients with known effect (per mL) 200 mg fructose, 400 mg sucrose, 1.8 mg methyl parahydroxybenzoate (E218), 0.2 mg propyl parahydroxybenzoate (E 216) For the…
Objective: To lay down the procedure for Sampling and testing of sterile surgical gloves. Scope: This SOP is applicable for sampling and testing of sterile surgical gloves. Responsibility: Personnel (Microbiology-QC) shall be responsible for sampling and testing of sterile surgical gloves. Executive/ Officer shall be responsible for ensuring the compliance to the procedure. Head–Microbiology shall…
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STABILITY TESTING OF NEW DRUG PRODUCTS Q1A(R2) Drug Product General Photostability Testing Selection of Batches Container Closure System Specification Testing Frequency Storage Conditions Stability Commitment Evaluation Statements/Labeling Drug Product General The design of the formal stability studies for the drug product should be based on knowledge of the behavior and properties of the drug substance…
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STABILITY TESTING OF NEW DRUG SUBSTANCES Q1A(R2) COVER NOTE FOR REVISION OF Q1A(R) The changes made in Q1A(R) that result from adoption of ICH Q1F “Stability Data Package for Registration Applications in Climatic Zones III and IV”. These changes are: The intermediate storage condition has been changed from 30°C ± 2°C/60% RH ± 5% RH…
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PHARMACEUTICAL DEVELOPMENT I. INTRODUCTION II. PHARMACEUTICAL DEVELOPMENT A. Components of the Drug Product 1. Drug Substance 2. Excipients B. Drug Product 1. Formulation Development 2. Overages 3. Physicochemical and Biological Properties C. Manufacturing Process Development D. Container Closure System E. Microbiological Attributes F. Compatibility III. GLOSSARY INTRODUCTION The Pharmaceutical Development provides an opportunity to…
