Engineering Documentation in Pharmaceutical Industry

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Engineering Documentation in Pharmaceutical Industry Heat Load Calculations. AHU Zoning drawing with pressure differentials. Airflow diagram. Ducting layout. Piping Layout. Hepa Box G.A. Man Movements layout Material Movements layout The layout of Pressure difference and area classification in production Area Qualification Area Mapping Commissioning Report of HVAC System Airflow & ACPH (Room wise) Filter Integrity … Read more

HPLC Chromatography

HPLC Chromatography (Questions & Answers) HPLC is a chromatographic technique that employs a liquid mobile phase to separate and analyze components of a sample. Unlike traditional liquid chromatography, HPLC utilizes high pressure to force the liquid mobile phase through a packed column, enhancing separation efficiency and speeding up analysis times. This increased pressure allows for … Read more

Dissolution (Question & Answer)

Dissolution (Question & Answer) 1. Question: What is dissolution? Answer:  Dissolution is the time require to release the active drugs substances into liquid form in a dissolution medium under setup conditions (RPM, Time, and Temperature). 2. Question: What is USP chapter No. for Dissolution? Answer: USP chapter No, <711> 3. Question: How many Types of … Read more

Interview Questions & Answers (Quality Assurance)

Interview Questions & Answers (Quality Assurance) 1.What is Quality Assurance : Quality Assurance is a deep concept covering all matters that individually or collectively influence the quality of a product. It is the complete & whole of the arrangements made with the object of ensuring that the manufactured products are of the quality required for their … Read more

OOS (Out of Specification) As PER USFDA & MHRA

OOS (Out of Specification) Definition: It is defined as those results of the in-process or Finished which has been sed products testing, which falling out specified limit or acceptance Criteria which has been specified in the official Monograph or  Product registered  Specification. OOS was found due to the following reasons: Laboratory Related OOS Process Related … Read more

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

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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. Building and civil works – … Read more

SPECIFIC REQUIREMENTS FOR MANUFACTURE OF TOPICAL PRODUCTS

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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 shall be filtered through at … Read more

Environmental Monitoring

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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 filter integrity testing (smoke testing) … Read more

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

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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 mix-ups. The manufacturing area shall … Read more

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

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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 dust control manufacturing systems shall … Read more

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. (6) Date of commencement of … Read more

In-process Checks during Tertiary Packaging Operations

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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 corrugated boxes. Insertion of Packer’s … Read more

In-process Checks during Secondary Packaging Operations

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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 Distorted Tablets Improper Batch coding … Read more

In-process Checks during Primary Packaging Operations

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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 Tablets Foil shifting: Foil shifting … Read more

Optimal HVAC Systems for Non-Sterile Pharmaceutical Environments: Ensuring Quality and Compliance

Optimal HVAC Systems for Non-Sterile Pharmaceutical Environments: Ensuring Quality and Compliance In the pharmaceutical industry, maintaining a controlled environment is crucial to ensure product quality, safety, and regulatory compliance. HVAC (Heating, Ventilation, and Air Conditioning) systems play a vital role in non-sterile pharmaceutical facilities by providing appropriate temperature, humidity, and air quality control. These systems … Read more

Temperature mapping of storage areas: Ensuring Reliable Environmental Control and Compliance

Temperature mapping of storage areas: Ensuring Reliable Environmental Control and Compliance In various industries, maintaining proper temperature control within critical areas is essential to ensure product quality, integrity, and regulatory compliance. Temperature mapping of storage areas is a systematic process that involves monitoring and analyzing temperature distribution within a defined space, such as a storage … Read more

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 filters. A format is also … Read more

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 that no errors have occurred … Read more

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 executing sanitary control of the … Read more

Vial Washing Machine: Streamlining Sterile Pharmaceutical Packaging

Vial Washing Machine: Streamlining Sterile Pharmaceutical Packaging In the pharmaceutical industry, maintaining the integrity and cleanliness of packaging materials is crucial for ensuring the safety and efficacy of drugs. Vial washing machines play a vital role in the production of sterile pharmaceuticals by efficiently cleaning and sanitizing vials before they are filled with medications. These … Read more