ETIF

Attendees, exhibitors & solutions

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Industry trends

Key trends shaping this market and its wider industry.

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Frequently asked

Glossary

1

ANMAT

Administración Nacional de Medicamentos, Alimentos y Tecnología Médica, the Argentine regulator that authorises pharmaceutical establishments, products and clinical studies and that carries out GMP inspections of plants serving the Argentine market.

2

BPM / GMP

Buenas Prácticas de Fabricación, the Spanish-language term for good manufacturing practice: the quality system governing premises, equipment, documentation, personnel and release that a pharma plant must operate to be licensed in Argentina and to export.

3

Validation (IQ / OQ / PQ)

The documented evidence that a facility, utility or process does what it claims. Installation qualification checks the equipment was built and installed as specified, operational qualification checks it runs across its operating range, and performance qualification checks it delivers a consistent product or utility at production scale.

4

Cleaning validation

The study proving that a cleaning procedure removes active ingredient, detergent and microbial residues between products, typically built on worst-case product/equipment combinations, swab and rinse sampling, and defined acceptance limits.

5

Media fill (process simulation)

An aseptic filling trial using nutrient medium instead of product, incubated to detect microbial contamination, used to demonstrate that the aseptic filling process and operator interventions remain under control.

6

Cleanroom classification (ISO 14644-1)

The grading of air cleanliness by particle count per cubic metre. Pharmaceutical rooms are commonly specified as ISO 5, ISO 7 or ISO 8, which map closely to EU GMP grades A, B and C/D depending on the activity performed inside them.

7

Grade A / B / C / D

The EU GMP cleanroom grades used widely in Latin American practice: Grade A is the critical aseptic filling zone, Grade B the surrounding background, and Grades C and D cover less critical stages up to terminal sterilization or non-sterile production.

8

WFI (water for injection)

Highly purified water used in sterile product manufacture, produced by distillation or validated reverse osmosis plus ultrafiltration, stored and distributed in a continuously circulating loop above 65 degrees C or otherwise validated against microbial growth.

9

F0 and biological indicators

Measures used to validate steam sterilization: F0 expresses lethality accumulated at 121 degrees C, while biological indicators (typically Geobacillus stearothermophilus spores) provide the physical challenge that proves the cycle kills resistant organisms.

10

Single-use systems (SUS)

Disposable bioreactors, bags, mixers and transfer lines used to reduce cleaning validation and changeover time in biotech and sterile operations, requiring their own extractables/leachables and supplier qualification package.

11

Serialization and aggregation

Unit-level coding of each pack with a product code plus serial number, then linking packs into cases and pallets so a batch can be traced and verified at any point in the distribution chain.

12

ICH Q9 / Q10

The international guidance most plants in the region align to: Q9 covers quality risk management (risk assessment and control applied to processes and changes) and Q10 describes the pharmaceutical quality system spanning the product lifecycle.

13

Technology transfer

The structured transfer of a process, analytical method or product from development, another site or a contract manufacturer into commercial production, including documentation, training, engineering runs and comparability evidence.

14

Cold chain qualification

The testing and documentation that a 2-8 degrees C (or other specified) distribution route keeps product within range, covering shippers, temperature data loggers, lane risk assessment and excursion handling.

15

Congress module

The ETIF registration unit: a module bundles three conference sessions, so attendees can build a programme around a specific technical track rather than buying the full congress.