Basic pharmaceutical operations pdf

A quality management system should contain a set of rules and procedures that define all the processes that occur within the pharmacy office, in the different areas that affect the customer, the internal organization and the customer, thereby seeking to achieve maximum satisfaction of the users of the pharmacy.

Standard Operating Procedures, Standard Operating Protocols (SOPs) or Standard Operating Procedures (SOPs) are written and approved procedures that specifically describe the activities that are carried out in the development of a pharmaceutical process or activity related to it. These procedures serve, therefore, to be able to assess and accredit the quality of the work and services provided in the pharmacy.

– Copies of the pharmacy’s standard operating procedures (SOPs) must be signed and accepted by the team members and must always be available and accessible to them.

What are standard operating procedures?

Standard Operating Procedures (SOPs) are written documents that describe the specific sequence of operations and methods to be applied in the laboratory for a given purpose.

What is a standard protocol?

Standard Operating Procedures, Standard Operating Protocols (SOPs) or Standard Operating Procedures (SOPs) are written and approved procedures that specifically describe the activities carried out in the development of a pharmaceutical process or activity …

What are the basic pharmaceutical operations?

Basic Pharmaceutical Operations: which deal with the manipulations of processes to get an active ingredient into a dosage form, e.g. lyophilization, spraying, mixing and compression to obtain a tablet.

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Self-inspection in a pharmacy

A quality management system should contain a set of rules and procedures that define all the processes that take place within the pharmacy office, in the different areas that affect the customer, the internal organization and the customer, thus seeking to achieve maximum satisfaction of the pharmacy users.

Standard Operating Procedures, Standard Operating Protocols (SOPs) or Standard Operating Procedures (SOPs) are written and approved procedures that specifically describe the activities that are carried out in the development of a pharmaceutical process or activity related to it. These procedures are therefore used to assess and certify the quality of the work and services provided in the pharmacy.

– Copies of the pharmacy’s standard operating procedures (SOPs) must be signed and accepted by the team members and must always be available and accessible to them.

What does the acronym PNT stand for?

The acronym PNT is used in some countries to refer to non-traditional advertising. It is an advertisement that is inserted into the development of a radio or television program, and is not broadcast in a separate segment as usual.

How to develop a SOP?

SOPs should be written in a clear, visual, concrete and concise manner, so that they can be easily understood by the personnel who will apply them, without doubts in their interpretation. Graphic description and process maps are of great help for this purpose (Berger and Guillard, 2001; Pardo-Alvarez, 2018).

Why is it important to have a customer service protocol in the pharmacy?

“The way we treat our customers/patients defines the perception they have of us as professionals and of our pharmacy.” From the above we extract that one of the first benefits we find in good service is that it will help us to build customer loyalty.

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Standard laboratory work procedures

Law 25/1990, of December 20, 1990, on Medicines, regulates in its articles 35 and 36 the sanitary requirements for master formulas and officinal preparations. Thus, paragraph 3 of the aforementioned article 35, relating to magistral formulas, establishes that in the preparation of these formulas, the rules of correct manufacture and quality control will be observed. For its part, paragraph a) of article 36 of the aforementioned Law, regarding officinal preparations, establishes that these must be listed and described by the National Formulary. In this sense, paragraph 5 of article 55 of the same Law provides that the National Formulary will contain the standardized master formulas and officinal preparations recognized as drugs, their categories, indications and raw materials involved in their composition or preparation, as well as the rules for their correct preparation and control.

On the other hand, in its second transitory provision, it establishes that, until the National Formulary is approved and published, the elaboration of magistral formulas and officinal preparations regulated in articles 35 and 36 will be adjusted to the general principles established in this Law and to the technical and scientific standards currently accepted.

What are the types of excipients?

Types of excipients

Colorants: used to improve their appearance. Preservatives: necessary to extend the shelf life of the product. Diluents (such as vegetable cellulose or dicalcium phosphate): used to fill a tablet or capsule and make the presentation easier to consume the pharmaceutical formula.

What is the organization of a pharmacy like?

We must structure the pharmacy by departments: Warehouse, commercial area, purchasing area, administration, the pharmacy area itself, human resources and the management area. … The management of the internal organization is also key to obtain profitability in the pharmacy.

What is non-traditional advertising?

Non-traditional advertising is that which we find in mass and non-mass media in formats that are not pre-established.

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Sample Standard Operating Procedure

Dr. Enrique Benéitez Palomeque publishes “Cien Procedimientos Normalizados de Trabajo, básicos para la Industria Farmacéutica” (One Hundred Standard Operating Procedures, basic for the Pharmaceutical Industry), a Practical Application Reference Guide. It is an indispensable tool for the Pharmaceutical and Allied Industries. Enrique Benéitez explained his new work in detail: “This is not a simple manual or protocol, but a work of considerable length and scope. It is a technical treatise for application in the Pharmaceutical Industry and the practical resolution of a series of technical problems”.

The purpose of the work is to assist in the implementation of a work system adapted to the Good Manufacturing Practices for medicines, information necessary for the different departments, such as technical management, quality control, industrial management, shipping, manufacturing, personnel training, engineering and maintenance and warehouses.

By Rachel Robison

Rachel Robison is a blogger who collects information on court filings and notices.