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SPECIFIC REQUIREMENTS FOR MANUFACTURE OF METERED – DOSE INHALERS (MDI)

SPECIFIC REQUIREMENTS FOR MANUFACTURE OF METERED–DOSE INHALERS (MDI) General .– Manufacture of Metered-Dose-Inhalers shall be done under conditions which shall ensure minimum microbial and particulate contamination. Assurance of the quality of components and the bulk product is very important. Where medicaments are in suspended state, uniformity of suspension shall be established. …

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SPECIFIC REQUIREMENTS FOR MANUFACTURE OF TOPICAL PRODUCTS

SPECIFIC REQUIREMENTS FOR MANUFACTURE OF TOPICAL PRODUCTS i.e. EXTERNAL PREPARATIONS (CREAMS, OINTMENTS, PASTES, EMULSIONS, LOTIONS, SOLUTIONS, DUSTING POWDERS, AND IDENTICAL PRODUCTS). The entrance to the area where topical products are manufactured shall be through a suitable airlock. Outside the airlock, insectocutors shall be installed. The air to this manufacturing area …

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Environmental Monitoring

Environmental Monitoring – All environmental parameters listed under para 3.1 to 3.10 shall be verified and established at the time of installation and thereafter monitored at periodic intervals. The recommended frequencies of periodic monitoring shall be as follows: ( a ) Particulate monitoring in air – 6 Monthly (b) HEPA …

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SPECIFIC REQUIREMENTS FOR MANUFACTURE OF ORAL LIQUIDS (SYRUPS, ELIXIRS, EMULSIONS AND SUSPENSIONS)

SPECIFIC REQUIREMENTS FOR MANUFACTURE OF ORAL LIQUIDS (SYRUPS, ELIXIRS, EMULSIONS AND SUSPENSIONS) Building And Equipment – The premises and equipment shall be designed, constructed, and maintained to suit the manufacturing of Oral Liquids. The layout and design of the manufacturing area shall strive to minimize the risk of cross-contamination and …

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SPECIFIC REQUIREMENTS FOR MANUFACTURE OF ORAL SOLID DOSAGE FORMS (TABLETS AND CAPSULES)

SPECIFIC REQUIREMENTS FOR MANUFACTURE OF ORAL SOLID DOSAGE FORMS (TABLETS AND CAPSULES) The processing of dry materials and products creates problems of dust control and cross-contamination. Special attention is, therefore, needed in the design, maintenance, and use of premises and equipment in order to overcome these problems. Wherever required, enclosed …

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Documentation for Manufacture of Sterile products

Documentation for Manufacture of Sterile products The manufacturing records relating to manufacture of sterile products shall indicate the following details: – (1) Serial number of the Batch Manufacturing Record. (2) Name of the product. (3) Reference to Master Formula Record. (4) Batch / Lot number. (5) Batch / Lot size. …

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In-process Checks during Tertiary Packaging Operations

In-process Checks during Tertiary Packaging Operations of cartons/ shrink-wrapped units in one corrugated box / LDPE bag: Count the no. of cartons / shrink wrapped units in one corrugated box / LDPE bag and verify with the Batch Packing Record. Stencil on corrugated boxes: Check the stencil details on the …

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In-process Checks during Secondary Packaging Operations

In-process Checks during Secondary Packaging Operations Performed in In-process quality checks as pre-defined frequency in BPR and to be sorted out the strips/blister with below-mentioned tablet defects before packed in carton or during Packing Broken Tablets Laminated Tablets Chipped Tablets Discoloured Tablets With Black particles Tablets With foreign particle Tablets …

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In-process Checks during Primary Packaging Operations

In-process Checks during Primary Packaging Operations  (Blister / Strip Packing) Record the temperature and relative humidity of the Packaging area. Tablets and Capsules: Following defect /Issue to be sorted out before strip/blister sealing Broken Tablets Laminated Tablets Chipped Tablets Discoloured Tablets With Black particles Tablets With foreign particle Tablets Distorted …

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HVAC systems for non-sterile pharmaceutical as per WHO TRS. 937, 2006 ,Annex 2

WHO Technical Report Series, No. 937, 2006 ,Annex 2 Supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms 1. Introduction 2. Scope of document 3. Protection 3.1 Products and personnel 3.2 Air filtration 3.3 Unidirectional airflow 3.4 Infiltration 3.5 Cross-contamination 3.6 Temperature …

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Temperature mapping of storage areas – TRS 961, Annex 9

Temperature mapping of storage areas (WHO Technical Report Series, No. 961, 2011, Annex 9) The purpose of a temperature mapping study is to document and control the temperature distribution within a storage area. Temperature mapping of storage areas is a systematic mapping procedure in any cold room, freezer room, or …

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Observations & Compliances response of GMP Inspections

Observations & Compliances response of GMP Inspections Observations 1: In the DM water plant, there were no records maintained for the change of air filters from the compressor to the degasser. Response: The procedure for the replacement of filters has been incorporated in the SOP for the replacement of cartridge …

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Code of Federal Regulations (21CFR 211)

Organization and Personnel Responsibilities of quality control unit. (a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure …

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ANVISA – The Brazilian Health Surveillance Agency

The Brazilian Health Regulatory Agency (Anvisa) is an autarchy linked to the Ministry of Health, part of the Brazilian National Health System (SUS) as the coordinator of the Brazilian Health Regulatory System (SNVS), present throughout the national territory. Anvisa’s role it to promote the protection of the population’s health by …

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VIAL WASHING MACHINE PQ PROTOCOL

VIAL WASHING MACHINE PQ PROTOCOL TABLE OF CONTENTS S. No. Description 1.0 Protocol approval 2.0 Overview 2.1 Purpose 2.2 Scope 2.3 Responsibilities and identification of execution team 3.0 Pre-Validation requirement 4.0 Equipment description 5.0 Validation procedure 6.0 Sampling plan and Acceptance criteria 7.0 Validation report 8.0 Validation approval 9.0 Observed …

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New Product Design and Development Process

New Product Design and Development Process Objective To lay down a Procedure for New Product Design and Development Process. Scope This Standard Operating Procedure is applicable to pharmaceutical formulation plants. Responsibility Head, Clinical Research : Conducting Clinical Trials as per the Good Clinical Practices and review and compilation of data …

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Technical Directions for Drug Product Manufacturing

Preparation, Approval, Review and Control of Technical Directions for Manufacture of Drug Products. Objective To lay down a procedure for the Preparation, Approval, Review and Control of Technical Directions for Manufacture of Drug Products. Scope This Standard Operating Procedure is applicable for preparation and implementation of Technical Directions for all …

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Un-Planned Deviation -3 in Pharma

Un-Planned Deviation Details for Deviation No.______________ Department                       :               Production Investigation starts date:             Investigation completion date: INVESTIGATION TEAM S.No. Name Designation Department 1.   Production Head Production 2.   Production Manager Production 2.   Engineer Technologist Production 4.   QA Officer Quality Assurance 5.   QA Head Quality Assurance …

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Un-Planned Deviation -II in Pharma

Un-Planned Deviation – II in Pharma Details for Deviation No. ________ Department                                         :           Production Investigation start date                      :           Investigation completion date:           INVESTIGATION TEAM S.No. Name Designation Department 1. Production Head Production 2. Production Manager Production 2. EngineerTechnologist Production 4. QAOfficer Quality Assurance 5. QA Head Quality Assurance   …

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Un-Planned Deviation in Pharma

Un-Planned Deviation in Pharma Investigation Report Description of Deviation: The document entry of dispensing and cleaning records is not recorded by the respective operators. Type of deviation:  Un-Planned Deviation Class of Deviation:  Minor Date of investigation:   Department:  Warehouse Date of deviation Observed:   Investigations start date:   Investigation completion date:   INVESTIGATION TEAM …

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