ICH(Ichthyophthirius multifiliis) Definition on Pharma GMP

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration.

 

Dimenhydrinate BP/USP CAS No : 523-87-5

 

Ondansetrone HCL BP / USP CAS No : 103639-04-9

 

Acceptance Criteria

Numerical limits, ranges, or other suita-ble measures for acceptance of test re-sults.

Active Pharmaceutical Ingredient (API) (or Drug Substance)

Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.

 

API Starting Material

A raw material, intermediate, or an API that is used in the production of an API and that is incorporated as a significant structural fragment into the structure of the API. An API Starting Material can be an article of commerce, a material purchased from one or more suppliers under contract or commercial agreement, or produced in-house. API Starting Materials are normally of defined chemical properties and structure.

 

Batch (or Lot)

A specific quantity of material produced in a process or series of processes so that it is expected to be homogeneous within specified limits. In the case of continu-ous production, a batch may correspond to a defined fraction of the production. The batch size can be defined either by a fixed quantity or by the amount pro-duced in a fixed time interval.

 

Batch Number (or Lot Number)

A unique combination of numbers, let-ters, and/or symbols that identifies a batch (or lot) and from which the pro-duction and distribution history can be determined.

 

Bioburden

The level and type (e.g. objectionable or not) of micro-organisms that can be pre-sent in raw materials, API starting mate-rials, intermediates or APIs. Bioburden should not be considered contamination unless the levels have been exceeded or defined objectionable organisms have been detected.

 

Calibration

The demonstration that a particular instrument or device produces results within specified limits by comparison with those produced by a reference or traceable standard over an appropriate range of measurements.

 

Computer System

A group of hardware components and associated software, designed and as-sembled to perform a specific function or group of functions.

 

Computerized System

A process or operation integrated with a computer system.

Contamination

The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or onto a raw material, intermediate, or API during production, sampling, packaging or re-packaging, storage or transport.

 

Contract  Manufacturer

A manufacturer performing some aspect of manufacturing on behalf of the original manufacturer.

 

Critical

Describes a process step, process condition, test requirement, or other relevant parameter or item that must be controlled within predetermined criteria to ensure that the API meets its specifi-cation.

 

Cross-Contamination

Contamination of a material or product with another material or product.

 

Deviation

Departure from an approved instruction or established standard.

 

Drug (Medicinal) Product

The dosage form in the final immediate packaging intended for marketing. (Reference Q1A)

 

Drug Substance

See Active Pharmaceutical Ingredient

 

Expiry Date (or Expiration Date)

The date placed on the container/labels of an API designating the time during which the API is expected to remain within established shelf life specifica-tions if stored under defined conditions, and after which it should not be used.

 

Impurity

Any component present in the interme-diate or API that is not the desired enti-ty.

 

Impurity Profile

A description of the identified and uni-dentified impurities present in an API.

 

In-Process Control (or Process Control)

Checks performed during production in order to monitor and, if appropriate, to adjust the process and/or to ensure that the intermediate or API conforms to its specifications.

 

Intermediate

A material produced during steps of the processing of an API that undergoes further molecular change or purification before it becomes an API. Intermediates may or may not be isolated. (Note: this Guide only addresses those intermedi-ates produced after the point that the company has defined as the point at which the production of the API be-gins.)

 

Manufacture

All operations of receipt of materials, production, packaging, repackaging, labelling, relabelling, quality control, release, storage, and distribution of APIs and related controls.

 

Material

A general term used to denote raw mate-rials (starting materials, reagents, sol-vents), process aids, intermediates, APIs and packaging and labelling materials.

 

Mother Liquor

The residual liquid which remains after the crystallization or isolation processes. A mother liquor may contain unreacted materials, intermediates, levels of the API and/or impurities. It may be used for further processing.

 

Packaging Material

Any material intended to protect an in-termediate or API during storage and transport.

 

Procedure

A documented description of the opera-tions to be performed, the precautions to be taken and measures to be applied directly or indirectly related to the man-ufacture of an intermediate or API.

 

Process Aids

Materials, excluding solvents, used as an aid in the manufacture of an intermedi-ate or API that do not themselves partici-pate in a chemical or biological reaction (e.g. filter aid, activated carbon, etc).

Process Control

See In-Process Control.

 

Production

All operations involved in the prepara-tion of an API from receipt of materials through processing and packaging of the API.

 

Qualification

Action of proving and documenting that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results. Qualification is part of validation, but the individual qualification steps alone do not constitute process validation.

 

Quality Assurance (QA)

The sum total of the organised arrange-ments made with the object of ensuring that all APIs are of the quality required for their intended use and that quality systems are maintained.

 

Quality Control (QC)

Checking or testing that specifications are met.

 

Quality Unit(s)

An organizational unit independent of production which fulfills both Quality Assurance and Quality Control responsi-bilities. This can be in the form of sepa-rate QA and QC units or a single individ-ual or group, depending upon the size and structure of the organization.

 

Quarantine

The status of materials isolated physical-ly or by other effective means pending a decision on their subsequent approval or rejection.

 

Raw Material

A general term used to denote starting materials, reagents, and solvents intend-ed for use in the production of interme-diates or APIs.

 

Reference Standard, Primary

A substance that has been shown by an extensive set of analytical tests to be au-thentic material that should be of high purity. This standard can be: (1) obtained from an officially recognised source, or (2) prepared by independent synthesis, or (3) obtained from existing production material of high purity, or (4) prepared by further purification of existing pro-duction material.

 

Reference Standard, Secondary

A substance of established quality and purity, as shown by comparison to a pri-mary reference standard, used as a refer-ence standard for routine laboratory analysis.

 

Reprocessing

Introducing an intermediate or API, in-cluding one that does not conform to standards or specifications, back into the process and repeating a crystallization step or other appropriate chemical or physical manipulation steps (e.g., distil-lation, filtration, chromatography, mill-ing) that are part of the established man-ufacturing process. Continuation of a process step after an in-process control test has shown that the step is incom-plete is considered to be part of the nor-mal process, and not reprocessing.

 

Retest Date

The date when a material should be re-examined to ensure that it is still suitable for use.

 

Reworking

Subjecting an intermediate or API that does not conform to standards or specifi-cations to one or more processing steps that are different from the established manufacturing process to obtain ac-ceptable quality intermediate or API (e.g., recrystallizing with a different sol-vent).

 

Signature (signed)

See definition for signed

Signed (signature) The record of the individual who performed a particular action or review. This record can be ini-tials, full handwritten signature, person-al seal, or authenticated and secure elec-tronic signature.

 

Solvent

An inorganic or organic liquid used as a vehicle for the preparation of solutions or suspensions in the manufacture of an intermediate or API.

 

 

Miconazole Nitrate IP/BP/EP/USP CAS No : 22832-87-7

 

Miconazole IP/BP/EP/USP CAS No : 22916-47-8

 

Keywords

Dimenhydrinate , Miconazole Nitrate , API

amarhealthcare

Amar Healthcare, Quality Pharmaceutical API Intermediates Manufacturers in India. Specializing in the development of Pharmaceutical Ingredients like Bulk APIs & Drug Intermediates. AMAR HEALTHCARE - API & INTERMEDIATES MANUFACTURERS IN INDIA | Active Pharmaceutical Ingredients (API) | pharma intermediates manufacturers | Diphenhydramine HCL IP/BP/EP/USP CAS No 147-24-0 | Chlorpheniramine Maleate IP/BP/EP/USP CAS No : 113-92-8 | Manufacturer of 4-Chlorobenzophenone CAS No : 134-85-0 | Active Pharmaceutical Ingredients (API) | api pharma companies in india | active pharmaceutical ingredient list | active pharmaceutical ingredient manufacturing | what is api and formulation in pharma | active pharmaceutical ingredient manufacturing process | List of Active Pharmaceutical Ingredients (API) Products | top api manufacturers in india | api drugs manufacturer | Pharma API Manufacturers in India | intermediate manufacturers in india | pharma intermediates manufacturers | api intermediates | intermediate suppliers | pharmaceutical intermediates list | api intermediates market | api manufacturing | Manufacturer of Diphenhydramine HCL IP/BP/EP/USP CAS No 147-24-0 | Diphenhydramine HCL IP/BP/EP/USP CAS No 147-24-0 | Diphenhydramine hydrochloride | Diphenhydramine hydrochloride, 147-24-0, Manufacturer | Diphenhydramine Hydrochloride 147-24-0 | Diphenhydramine hydrochloride (CAS 147-24-0) | CAS No. 147-24-0, diphenhydramine hydrochloride | Application of Diphenhydramine HCL IP/BP/EP/USP CAS No : 147-24-0 | Chlorpheniramine Maleate IP/BP/EP/USP | Manufacturer of Chlorpheniramine Maleate IP/BP/EP/USP CAS No : 113-92-8 | Chlorpheniramine Maleate IP/BP/EP/USP CAS No : 113-92-8 | Application of Chlorpheniramine Maleate IP/BP/EP/USP CAS No : 113-92-8 | Chlorpheniramine Maleate | Chlorpheniramine Maleate (CAS 113-92-8) Manufacturers | Chlorpheniramine maleate, 113-92-8, Manufacturer, Supplier | Chlorpheniramine Maleate 113-92-8 | Pheniramine Maleate IP/BP/EP/USP | Manufacturer of Pheniramine Maleate IP/BP/EP/USP CAS No : 132-20-7 | Application of Pheniramine Maleate IP/BP/EP/USP CAS No : 132-20-7 | Pheniramine Maleate 132-20-7 | CAS 132-20-7, Pheniramine Maleate manufacturer & Supplier | Pheniramine maleate - C20H24N2O4 | | Pheniramine Maleate IP/BP/EP/USP CAS No : 132-20-7 | Pheniramine Maleate CAS No 132-20-7 | Dexchlorpheniramine Maleate IP / BP / USP | Manufacturer of Dexchlorpheniramine Maleate IP / BP / USP CAS No : 2438-32-6 | Application of Dexchlorpheniramine Maleate IP / BP / USP CAS No : 2438-32-6 | Dexchlorpheniramine Maleate IP / BP / USP CAS No : 2438-32-6 | Dexchlorpheniramine Maleate CAS No 2438-32-6 | DEXCHLORPHENIRAMINE MALEATE | 2438-32-6 | Dexchlorpheniramine Maleate | 2438-32-6 Dexchlorpheniramine maleate | CetrizineDihydrochloride BP/EP | Manufacturer of CetrizineDihydrochloride BP/EP CAS No : 83881-52-1 | CetrizineDihydrochloride BP/EP CAS No : 83881-52-1 | CetrizineDihydrochloride CAS No 83881-52-1 | Application of CetrizineDihydrochloride BP/EP CAS No : 83881-52-1 | Cetirizine Dihydrochloride 83881-52-1 | cetirizine hydrochloride | Dimenhydrinate BP/USP | Manufacturer of Dimenhydrinate BP/USP CAS No : 523-87-5 | Dimenhydrinate BP/USP CAS No : 523-87-5 | Application of Dimenhydrinate BP/USP CAS No : 523-87-5 | Dimenhydrinate 523-87-5 | Dimenhydrinate CAS No : 523-87-5 | Ondansetrone HCL BP / USP | Manufacturer of Ondansetrone HCL BP / USP CAS No : 103639-04-9 | Ondansetrone HCL BP / USP CAS No : 103639-04-9 | Ondansetrone CAS No 103639-04-9 | Application of Ondansetrone HCL BP / USP CAS No : 103639-04-9 | Ondansetron Hydrochloride 103639-04-9 | Ondansetron Hydrochloride, USP 103639-04-9 | CAS No.103639-04-9,Ondansetron hydrochloride Suppliers | Miconazole Nitrate IP/BP/EP/USP | Manufacturer of Miconazole Nitrate IP/BP/EP/USP CAS No : 22832-87-7 | Application of Miconazole Nitrate IP/BP/EP/USP CAS No : 22832-87-7 | Miconazole Nitrate IP/BP/EP/USP CAS No : 22832-87-7 | Miconazole Nitrate 22832-87-7 | Miconazole nitrate Supplier | Miconazole IP/BP/EP/USP | Manufacturer of Miconazole IP/BP/EP/USP CAS No : 22916-47-8 | Application of Miconazole IP/BP/EP/USP CAS No : 22916-47-8 | Miconazole IP/BP/EP/USP CAS No : 22916-47-8 | Miconazole Base, 22916-47-8, Manufacturer, Supplier India | Miconazole 22916-47-8 | Econazole Nitrate IP/BP/USP | Manufacturer of Econazole Nitrate IP/BP/USPCAS No : 24169-02-6 | Application of Econazole Nitrate IP/BP/USP CAS No : 24169-02-6 | Econazole Nitrate IP/BP/USP CAS No : 24169-02-6 | Econazole Nitrate 24169-02-6 | Econazole Nitrate IP/BP/USP CAS No : 24169-02-6 | Clotrimazole IP/BP/EP/USP | Manufacturer of Clotrimazole IP/BP/EP/USP CAS No : 23593-75-1 | Application of Clotrimazole IP/BP/EP/USP CAS No : 23593-75-1 | Clotrimazole IP/BP/EP/USP CAS No : 23593-75-1 | Clotrimazole 23593-75-1 | Clotrimazole IP/BP/EP/USP CAS No : 23593-75-1 | PiroctoneOlamine | Manufacturer of PiroctoneOlamine CAS No : 68890-66-4 | Application of PiroctoneOlamine CAS No : 68890-66-4 | PiroctoneOlamine CAS No : 68890-66-4 | PiroctoneOlamine 68890-66-4 | Piroctone olamine - CAS-Number 68890-66-4 | Mesalamine IP/BP/USP | Manufacturer of Mesalamine IP/BP/USP CAS No : 89-57-6 | Application of Mesalamine IP/BP/USP CAS No : 89-57-6 | Mesalamine IP/BP/USP CAS No : 89-57-6 | Mesalamine CAS No : 89-57-6 | Mesalamine 89-57-6 | 5-Aminosalicylic Acid 89-57-6 | Loxoprofen | Loxoprofen Active Pharmaceutical Ingredients (API) | Manufacturer of Loxoprofen CAS No : 68767-14-6 | Loxoprofen CAS No : 68767-14-6 | Loxoprofen 68767-14-6 | Application of Loxoprofen CAS No : 68767-14-6 | Loxoprofen . 68767-14-6 | Loxoprofen Sodium | Loxoprofen Sodium Active Pharmaceutical Ingredients (API) | Manufacturer of Loxoprofen Sodium CAS No : 80382-23-6 | Application of Loxoprofen Sodium CAS No : 80382-23-6 | Loxoprofen Sodium CAS No : 80382-23-6 | Loxoprofen Sodium 80382-23-6 Loxoprofen Sodium | Flurbiprofen | Flurbiprofen Active Pharmaceutical Ingredients (API) | Manufacturer of Flurbiprofen CAS No : 5104-49-4 | Application of Flurbiprofen CAS No : 5104-49-4 | Flurbiprofen CAS No : 5104-49-4 | Flurbiprofen 5104-49-4 | Chlorhexidine Base | Chlorhexidine Base Active Pharmaceutical Ingredients (API) | Manufacturer of Chlorhexidine Base CAS No : 55-56-1 | Application of Chlorhexidine Base CAS No : 55-56-1 | Chlorhexidine Base CAS No : 55-56-1 | Chlorhexidine Base 55-56-1 | chlorhexidine, 55-56-1 | Chlorhexidine Gluconate | Chlorhexidine Gluconate Active Pharmaceutical Ingredients (API) | Chemical Stucture of Chlorhexidine Gluconate | Manufacturer of Chlorhexidine Gluconate CAS No : 55-56-1 | Application of Chlorhexidine Gluconate CAS No : 55-56-1 | Chlorhexidine Gluconate CAS No : 55-56-1 | Chlorhexidine Gluconate 55-56-1 | 4-Chlorobenzophenone Intermediates | 4-Chlorobenzophenone | Manufacturer of 4-Chlorobenzophenone CAS No : 134-85-0 | 4-Chlorobenzophenone CAS No : 134-85-0 | 4-Chlorobenzophenone 134-85-0 | Application of 4-Chlorobenzophenone CAS No : 134-85-0 | 4-Chlorobenzophenone 134-85-0 Price | 4-Chlorobenzophenone | 4-Chloro benzhydryl piperazine | 4-Chloro benzhydryl piperazine Intermediates | Manufacturer of 4-Chloro benzhydryl piperazine CAS No : 303-26-4 | Application of 4-Chloro benzhydryl piperazine CAS No : 303-26-4 | 1-(4-Chlorobenzhydryl)piperazine 303-26-4 | 1-(4-Chlorobenzhydryl)piperazine | 303-26-4 | 1-(4-Chlorobenzhydryl)piperazine 303-26-4 | 4-chlorobenzhydryl piperazine synthesis | 1-(4-chlorobenzhydryl)piperazine uses | 4-chloro benzhydryl piperazine msds | 4-chlorobenzhydryl piperazine cas no | 1-(3-Chloropropyl)-1,3-Dihydro-2H-benzimidazolone Intermediates | 1-(3-Chloropropyl)-1,3-Dihydro-2H-benzimidazolone | Manufacturer of 1-(3-Chloropropyl)-1,3-Dihydro-2H-benzimidazolone CAS No : 62780-89-6 | Application of 1-(3-Chloropropyl)-1,3-Dihydro-2H-benzimidazolone CAS No : 62780-89-6 | 1-(3-Chloropropyl)-1,3-dihydro-2H-benzimidazol | 1-(3-Chloropropyl)-1,3-Dihydro-2H-benzimidazolone 62780-89-6 | Benzhydryl piperazine Intermediates | Benzhydryl piperazine | Manufacturer of Benzhydryl piperazine CAS No : 841-77-0 | Benzhydryl piperazine CAS No : 841-77-0 | Benzhydryl piperazine 841-77-0 | Application of Benzhydryl piperazine CAS No : 841-77-0 1-Benzhydrylpiperazine 841-77-0 | 841-77-0 - 1-Benzhydrylpiperazine | 9-Methyl-1,2,3,9- Tetrahydro-4-H Carbazole –4-one Intermediates | 9-Methyl-1,2,3,9- Tetrahydro-4-H Carbazole –4-one | 9-Methyl-1,2,3,9- Tetrahydro-4-H Carbazole –4-one CAS No : 27387-31-1 | 9-Methyl-1,2,3,9- Tetrahydro-4-H Carbazole –4-one 27387-31-1 Application of 9-Methyl-1,2,3,9- Tetrahydro-4-H Carbazole –4-one CAS No : 27387-31-1 | 1, 4, Benzodioxane carbonyl piperazine HCL/Base | 1, 4, Benzodioxane carbonyl piperazine HCL/Base CAS No : 70918-00-2 | 1, 4, Benzodioxane carbonyl piperazine HCL/Base 70918-00-2 | 1, 4, Benzodioxane carbonyl piperazine 70918-00-2 | Application of 1, 4, Benzodioxane carbonyl piperazine HCL/Base CAS No : 70918-00-2 | 2-(1-Piperazinylcarbonyl)-1,4-benzodioxane 70918-00-2 | 1-(1,4-Benzodioxane-2-carbonyl)piperazine | 70918-00-2 | 1-(2, 4-Dichloro phenyl)-2-(1H-Imidazol-yl) Ethanol | 1-(2, 4-Dichloro phenyl)-2-(1H-Imidazol-yl) Ethanol CAS No : 24155-42-8 | 1-(2, 4-Dichloro phenyl)-2-(1H-Imidazol-yl) Ethanol 24155-42-8 | alpha-(2,4-Dichlorophenyl)-1H-imidazole-1-ethanol | 24155-42-8|1-(2,4-Dichlorophenyl)-2-(1H-imidazol-1-yl)ethanol | 1-(2,4-Dichlorophenyl)-2-(1-imidazolyl)ethanol 24155-42-8 | 24155-42-8 α-(2,4-Dichlorophenyl)-1H-imidazole-1-ethanol | a-(2,4-Dichlorophenyl)-1H-imidazole-1-ethanol 24155-42-8 | 1-(4-Methoxy phenyl) Piperazine | 1-(4-Methoxy phenyl) Piperazine CAS No : 38212-30-5 | 1-(4-Methoxy phenyl) Piperazine 38212-30-5 | Application of 1-(4-Methoxy phenyl) Piperazine CAS No : 38212-30-5 | 1-(4-Methoxyphenyl)piperazine | C11H16N2O | 1-(4-Methoxyphenyl)piperazine 97 % | 1-(4-Methoxyphenyl)piperazine 38212-30-5 | 1-(2-MethoxyPhenyl) Piperazine HCl | 1-(2-MethoxyPhenyl) Piperazine HCl CAS No : 35386-24-4 | Application of 1-(2-MethoxyPhenyl) Piperazine HCl CAS No : 35386-24-4 | 1-(2-MethoxyPhenyl) Piperazine 35386-24-4 | 1-(2-Methoxyphenyl)piperazine 35386-24-4 | CAS No. 35386-24-4, 1-(2-Methoxyphenyl)piperazine Price | 1-(2-Methoxyphenyl)piperazine 35386-24-4 | Diphenyl acetonitrile | Diphenyl acetonitrile CAS No : 86-29-3 | Application of Diphenyl acetonitrile CAS No : 86-29-3 | Diphenyl acetonitrile 86-29-3 | Diphenylacetonitrile-86-29-3 | Diphenylacetonitrile CAS 86-29-3 | Diphenylacetonitrile 86-29-3 | 4-Fluoro Anisole | 4-Fluoro Anisole CAS No : 459-60-9 | 4-Fluoro Anisole 459-60-9 | Application of 4-Fluoro Anisole CAS No : 459-60-9 | 4-Fluoroanisole 459-60-9 Route Of Synthesis | 4-Fluoroanisole CAS:459-60-9 supplier manufacturer | 4-Fluoroanisole 459-60-9 | CAS No.459-60-9,4-Fluoroanisole Suppliers | 4-Fluoroanisole Exporter,Manufacturer,Supplier | 4 Fluoro Anisole 459-60-9 | 4-Fluoro-bromo benzene | 4-Fluoro-bromo benzene CAS No : 460-00-4 | Manufacturer of 4-Fluoro-bromo benzene CAS No : 460-00-4 | 4-Fluoro-bromo benzene 460-00-4 | Application of 4-Fluoro-bromo benzene CAS No : 460-00-4 | Para Bromo Fluoro Benzene - 460-00-4 | 4-Bromofluorobenzene 460-00-4 | 5-Nitro Salicylic acid | 5-Nitro Salicylic acid CAS No 96-97-9 | 2-Hydroxy-5-nitrobenzoic acid CAS 96-97-9 | CAS No. 96-97-9, 5-nitrosalicylic acid Price | 5-nitrosalicylic acid melting point | 5-nitrosalicylic acid manufacturers | molecular weight of 5-nitrosalicylic acid | 5-nitrosalicylic acid synthesis | 5-nitrosalicylic acid uses | 4-nitrosalicylic acid | 5-nitrosalicylic acid msds | 5-nitrosalicylaldehyde | 4-Bromo-2-fluorobiphenyl | 4-Bromo-2-fluorobiphenyl CAS No 41604-19-7 | 4-Bromo-2-fluorobiphenyl 41604-19-7 | 4-Bromo-2-fluorobiphenyl | 4-bromo-2-fluorobiphenyl synthesis | 4-bromo-2-fluorobiphenyl manufacturers in india | flurbiprofen |

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