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Frequently asked questions

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Distinguish static passbox and dynamic passbox?

Passbox is a specialized device used to transport objects between the same or other clean room in a clean room. It prevents dust from one environment from spreading to another during the transfer. Passbox is divided into two main categories: Static passbox and Dynamic passbox.

Static passbox is a basic type of passbox, only used to transfer items between two cleanroom environments with the same level of cleanliness. Static passboxes are usually equipped with magnetic interlock between the two doors, ensuring the two doors are not opened simultaneously and uv lights with 8W of power.

Dynamic passbox, also known as self-cleaning passbox, is used to deliver goods between two environments with different levels of cleanliness. Dynamic passbox is equipped with more specialized equipment such as fans, HEPA filters, UV lights with a capacity of 18W. Objects when introduced into Dynamic passbox are blown out of dust and disinfected with UV lights before being transferred to the other environment.

What is a clean room?

Clean room is a space where parameters such as urinary concentration, temperature, humidity, pressure, microbial limits … controlled and restricted to a certain limit to serve the activities that require strict safety and quality requirements.

What is an installation assessment (IQ)?

An installation assessment (IQ) is a documented confirmation that all important aspects of machinery/equipment/systems or auxiliary systems have been selected and constructed correctly and installed in accordance with established design requirements and specifications.

What is an Operational Assessment (OQ)?

An Operational Assessment (OQ) is documentation proving that machinery/equipment/systems operate as intended and are capable of operating appropriately in established technical descriptions.

What is performance assessment (PQ)?

Performance Assessment (PQ) is a document demonstrating that machines/equipment/systems are capable of continuous operation and delivering reproducibility with defined specifications and specifications for a long time.

What is process appraisal (PV)?

Process appraisal is a measure to ensure that the production process is capable of producing a consistent way of producing a product of satisfactory quality. Appraisal is the provision of evidence on file that the key steps in the production process are uniform and potentially repetitive.

What is a Hygiene Assessment (CV)?

It is documented evidence that hygiene procedures remove residues to pre-determined acceptable levels, taking into account factors such as batch size, dosage, toxicity level and equipment size.

What is the Original Assessment Plan (VMP)?

As a high-level document establishes an appraisal plan for the entire project and summarizes the entire philosophy and method of the manufacturer, used for establishing the a completeness of the appraisal activities.

Distinguishing assessment and appraisal in the pharmaceutical sector

Appraisal and evaluation are of the same nature in which the term “evaluation” is commonly used for devices, auxiliaries and systems, “appraisal” used for processes.

What is Calibrated?

Calibratation is the activity of determining and establishing the relationship between the measurement value of the measurement standard, the measuring instrument standard and the measurement value of the instrument-means to be measured.

What is inspection?

Inspection is the activity of evaluating and confirming the measurement technical characteristics of the measurement method according to the measurement technical requirements.

What is pharmaceuticals?

A material or product intended for human or veterinary use, expressed as a finished product or in the form of raw materials originally used for that form of finished product, shall be subject to the provisions of the pharmaceutical laws of the exporting country and/or the importing country.

What is cosmetics?

Is a substance or preparation used to come into contact with parts of the outside of the human body (skin, hair system, nails, toenails, lips and external genitals) or teeth and oral mucosa with the main purpose of cleansing, fragrant, changing appearance, form, regulate body odor, protect the body or keep the body in good condition.

What is health food?

These are products that are used to be added to the daily diet to maintain, enhance, improve the functions of the human body, reduce the risk of disease.

What is GMP?

It stands for Good Manufacturing Practice: Good Manufacturing Practice. This is a set of principles and standards on the production of drugs and raw materials for making drugs to ensure that drugs and raw materials for making drugs are always produced and inspected consistently according to quality standards suitable to the purpose of use and requirements of the drug circulation registration paper, Medicinal ingredients.

What is GSP?

It stands for Good Storage Practice: good preservation practice. This is a set of principles and standards on the preservation of drugs and raw materials for making medicines to ensure and maintain the best safety and quality of medicines and raw materials through adequate control throughout the storage process.

What is GLP?

It stands for Good Laboratory Practice: good laboratory practice. This is a set of principles and standards on quality management system related to the organization process and conditions for conducting non-clinical research in pharmaceutical activities for human health and environmental safety that are planned, implemented, monitored, recorded, storage and reporting.

What is GDP?

It stands for Good Distribution Practice: good practice of dispensing drugs, ingredients for making medicines. This is a set of principles and standards on the distribution of drugs and raw materials to ensure the quality of drugs and drug-making materials are maintained through full control of activities during distribution and avoiding the penetration of drugs and drug-making materials that are not allowed to circulate into the distribution system.

What is ISO 9001?

It is the international standard in building a quality management system for an organization. This is the common standard in all areas.

What is ISO 14001?

It is an international standard that sets out the criteria in the construction of an environmental management system. ISO 14001 helps organizations improve their environmental performance through more efficient use of resources and waste reduction, gaining competitive advantage and stakeholder trust.

What is ISO 22000?

It is the international standard that sets out the requirements of the food safety management system. A business in the food supply chain applied and iso 22000 certified is recognized as a unit with a good management system for food safety and hygiene and ensuring the supply of safe and quality food products to consumers.

What is ISO 13485?

It is the international standard that sets out the requirements of quality management systems in the design and manufacture of medical equipment.

What is ISO 15378?

It is the international standard that sets out the requirements of a quality management system in demonstrating the ability to supply grade 1 packaging materials for pharmaceuticals. This standard is based on ISO 9001 which references good manufacturing practice (GMP).

What is ISO 17025?

It is the international standard that sets out the general requirements for the capacity of laboratories and calibration. An organization that meets ISO 17025 will ensure the outputs of tests and calibrates are highly reliable.

What is EU-GMP/GMP-EU?

It stands for Good Manufacturing Practice ( European Union), which is a system of good pharmaceutical manufacturing practice guidelines issued by the European Union applicable to countries within the European Union and non-EUROPEAN UNION countries wishing to comply with this standard.

WHO-GMP/GMP-WHO là gì?

As a system of good pharmaceutical manufacturing practice guidelines issued by the World Health Organization (WHO), it is the minimum standard to apply in pharmaceutical production to most countries around the world.

What is PIC/S GMP?

PIC/S is a pharmaceutical inspection co-operation scheme (PIC/S). The purpose of this organization is to recognize each other in GMP inspection, ensuring that inspectors inspect the same items with the same criteria.

This is a good system of guidance for pharmaceutical production drafted and discussed by the pharmaceutical inspection cooperation agency.

What is HS-GMP/GMP-HS?

HS-GMP or GMP-HS stands for Good Manufacturing Practice-Health Supplement: good practice of producing health-protective foods. This is a set of principles and standards on the production of health-protective foods to ensure that health-protecting foods are always produced and checked consistently according to quality standards suitable to the purpose of use and requirements of product announcement paper.

What are the basic elements of GMP?

The five basic elements of GMP include:

– Human

– Equipment

– Materials

– Process

– Environment

What is CGMP-ASEAN?

CGMP-ASEAN stands for Cosmetic Good Manufacturing Practice-ASEAN is ASEAN’s guide to good cosmetic manufacturing practices as stipulated in the “Agreement on ASEAN Harmonized System in Cosmetic Management” by the ASEAN Cosmetics Commission.

What is an airlock?

A closed space is limited by two or more doors placed between two or more rooms to control the flow of air between areas of different or different levels of cleanliness.

Distinguish between microbiological implants and biosecurity cabinets?

Despite the same appearance, the microbiological implant cabinet and biosecurity cabinet have completely different uses. You need to understand and distinguish to avoid confusion during use.

The BioSafety Cabinet has the main task of protecting the manipulater and the surrounding environment from hazardous specimens during work, whether or not it may have the function of protecting specimens. The air in the workspace of the Biosecurity Cabinet is always maintained a caste flow with a stable speed and negative pressure compared to the surrounding environment to prevent the spread of the sample. Depending on the level of protection, biosecurity cabinets are classified into many types: Safety cabinets level I (lowest protection level), grade II (including 4 smaller types: A1, A2, B1, B2) and Level III (absolute protection).

In contrast to the Biosecurity Cabinet, the Laminar Flow Hood has the main task of protecting the specimen from pollution due to the surrounding air, it does not have the function of protecting users and the environment. The airflow in the bio-implant cabinet is also a casable flow but has a positive pressure to prevent outside air from entering the work area. Note not to use biological implant cabinets to manipulate hazardous samples.

Should I invest in air showers for clean rooms?

When it comes to cost, investing in an air shower actually only accounts for a tiny fraction of a cleanroom project as a whole, but its benefits are enormous.

Clean environments have clear workflows, and the employees in them most understand the importance of keeping the work environment unpolluted. But imagine if, for some negligence, the workflow was missed and just one shipment failed, the damage was much greater than the cost of investing in an air blower.

In addition, the equipping of air blower chambers for a clean working environment reduces the load on the ventilation system a lot. Since most of the dirt has been retained when employees go through the Air shower, the pressure placed on the HEPA filter plates as well as the amount of dust generated in the clean room is also much reduced, extending the life of the filter and reducing maintenance and maintenance costs.

If you compare the benefits that the Air Blower Chamber brings as above with a small investment, surely the installation of a Air Blower Chamber will bring you a lot more benefits.

We bought the equipment but doubted the supplier’s parameters were incorrect. Can GMP Groups help us evaluate?

Yes, we are a team of law-savvy managers, pharmacists, engineers, we have the capacity and experience to comprehensively evaluate the equipment according to the requirements of customers.

Why do manufacturing equipment need to conform to GMP standards?

Production equipment is an inseparable important component in pharmaceutical and cosmetic manufacturing plants. In order to build a factory meeting GMP standards, production equipment must conform to GMP standards.

Why does the construction of a manufacturing plant need to be consulted equipment?

The equipment consultancy helps investors choose production lines and equipment in accordance with their requirements, in accordance with GMP standards, minimizing investment costs and optimizing production efficiency.

GMP Groups advises and evaluates which technology lines and production equipment?

GMP Groups has a team with extensive experience in consulting and evaluating technology lines, pharmaceutical production equipment, functional foods, cosmetics, food.

Who is GMP Group’s technology and production equipment consulting team?

Our team consists of law-savvy administrators, pharmacists, engineers. This combination will help our reviews and advice be comprehensive, thoroughly many aspects of the product.

What does device profile mean?

Building a factory according to GMP standards, machinery records are required. On the one hand, it is the basis for the functional unit to evaluate and appraise the issuance of GMP certificates, on the other hand it is an effective tool to help investors manage equipment.

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