science

Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme

Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme is a science topic covered in the lgStudy science library. This page brings together a partial reference excerpt, illustrations, worked examples, real-world applications and a short study plan, so you can understand Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme rather than just read about it. In short: The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) are two international instruments between countries and pharmaceutical inspection authorities. The PIC/S is meant as an instrument to improve co-operation in the field of Good Manufacturing Practices between regulatory authorities and the pharmaceutical industry.

Key takeaways

Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme belongs to science; place it in that map before memorising details.
Learn the definition first, then one example that makes the definition concrete.
Connect Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme to a quantity you can measure, compute or draw — that is where exam questions come from.
Reproduce the core statement of Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme from memory before moving on to harder problems.

Reference excerpt

The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) are two international instruments between countries and pharmaceutical inspection authorities. The PIC/S is meant as an instrument to improve co-operation in the field of Good Manufacturing Practices between regulatory authorities and the pharmaceutical industry.

History The PIC (Pharmaceutical Inspection Convention) was founded in October 1970 by the European Free Trade Association (EFTA), under the title of the Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products. The initial members comprised the 10 member countries of EFTA at that time. In the early 1990s it was realized that because of an incompatibility between the Convention and European law, it was not possible for new countries to be admitted as members of PIC. European law did not permit individual EU countries that were members of PIC to sign agreements with other countries seeking to join PIC. As a consequence the Pharmaceutical Inspection Co-operation Scheme was formed on 2 November 1995. The Pharmaceutical Inspection Co-operation Scheme is an informal agreement between health authorities instead of a formal treaty between countries. PIC and the PIC Scheme, which operate together in parallel, are jointly referred to as PIC/S. PIC/S became operational in November 1995. Since its conception until 2003, PIC/S did not have a distinct legal identity. Its Secretariat was provided by the European Free Trade Association. Based on PIC/S meeting in June 2003, its committee decided to constitute itself as a Swiss Association in accordance with article 60 of the Swiss Civil Code which refer to other internationally active organizations established in Switzerland such as the International Committee of the Red Cross (ICRC). On 1 January 2004, PIC/S established its own Secretariat in Geneva, Switzerland.

Purpose PIC/S has a number of provisions intended to establish the following:

Mutual recognition of inspection between member countries, so that an inspection carried out by officials of one member country will be recognized as valid by other members. Equivalent principles of inspection methodology, so that it is understood that inspectors in each member country will be following the same best practices when carrying out inspections. Mechanisms for the training of inspectors. Harmonization of written standards of Good Manufacturing Practices. Lines of communication between member country inspectors/inspectorates.

Members

The following are the state members of PIC/S as of October 2021:

See also GxP Good automated manufacturing practice (GAMP) Corrective and preventive action (CAPA) Validation (drug manufacture) European Medicines Agency (EMEA) European Federation of Pharmaceutical Industries and Associations (EFPIA) Pharmaceutical Research and Manufacturers of America (PhRMA)

References

External links Official website European Federation of Pharmaceutical Industries and Associations (EFPIA) Japan Pharmaceutical Manufacturers Association (JPMA) Pharmaceutical Research and Manufacturers of America (PhRMA)

Illustrations

Worked examples

Example 1 — a first encounter with Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme

Start with the simplest possible case. Write down what Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme claims or describes in one sentence, then invent the smallest concrete situation in which that sentence is true. In science, the smallest case is usually a single object, a single equation or a single measurement. Check that every symbol or term in your sentence has a meaning in that case.

Example 2 — changing one variable

Take the situation from Example 1 and change exactly one quantity: double it, halve it, or set it to zero. Predict what should happen to Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme before you calculate. Comparing your prediction with the result is the fastest way to find out whether you understand the idea or only the words.

Example 3 — an exam-style question

Typical questions about Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme ask you to (a) state it precisely, (b) apply it to given data, and (c) explain a limitation. Practise writing all three answers in under five minutes; the third part is what separates a full-mark answer from an average one.

Applications of Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme

In research: Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme appears in science research whenever the underlying quantities have to be modelled precisely. Papers usually cite it as a starting assumption and then explore where it breaks down.
In technology and industry: Engineering practice reuses Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme in design rules, simulations and safety margins. Knowing the idea lets you read a specification sheet and understand why the numbers look the way they do.
In the classroom: Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme is common in secondary-school and first-year university syllabi. It links to neighbouring topics Intergovernmental organizations established by treaty, International organisations based in Switzerland, Pharmaceutical industry, so understanding it makes those chapters shorter.
In everyday life: Look for Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme outside the textbook — in sport, cooking, traffic, electronics or the sky above you. An example you found yourself is remembered far longer than one you were given.

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How to study Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme in 20 minutes

Read the reference excerpt below once, without taking notes.
Close the page and write down what Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme means in your own words.
Compare your version with the excerpt and mark what you missed.
Work through the three examples above with pen and paper.
Explain Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme out loud to somebody else — or to Teacher Smith in the lgStudy chat.

Frequently asked questions

What is Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme in simple terms?

Why does Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme matter?

Because it connects several science ideas at once: it gives you a definition you can apply, a quantity you can calculate, and a way to check whether a result is plausible.

How should I study Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme?

Read the excerpt, restate it from memory, then work through the examples and applications listed on this page. The five-step study plan above takes about twenty minutes.

What does this page cover?

It gives you a compact reference excerpt plus original lgStudy explanations, examples, applications and study material on Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme.