ORIENTATION OF PHARMACY PROFESSION

INTRODUCTION TO PHYSICAL PHARMACY

What is Pharmacy?

• Pharmacy is the art and science of preparing, compounding and dispensing medications. It also includes more modern services related to healthcare and the provision of drug and related information to the public. So it has a great role in diagnosis, prevention and treatment of diseases.
• The word ‘Pharmacy’ is derived from the Greek word ‘Pharmakon’ meaning drug. The word ‘Pharmacy’ has two meanings:
• General sense- it is a place or shop where drugs or medicines are sold.
• Prefessional sense- it is the profession, the members of which deal with drugs.

Pharmacist

• A pharmacist is the one who is educated and licensed to prepare and dispense drugs and to provide drug and related information to the public. An expert of drugs

“I am a Pharmacist.

I am a specialist in medications.

I am a custodian of medical information.

I am a companion of the physician.

I am a counselor to the patient.

I am a guardian of public health.

This is my calling. This is my pride.

  In short I am life saver.” 

​

Occupation and Profession

Occupation: The job by which someone earns for living.

Profession: An occupation characterized by:

• Extensive study
• Specialized training
• Specialized knowledge
• Professional organizations
• Ethical code and professional behavior
• Process of certification and licensing

Why choose pharmacy?

• I want a dynamic, people-oriented career in healthcare.
• I want diverse employment opportunities.
• I want a flexible work environment.
• I want a comfortable income.
• I want to be part of a respected profession.

Career opportunities:

• Production
• Quality Control(QC)
• Quality Assurance(QA)
• Research and development(R&D)
• Store
• Marketing(Local, Global)

​

​

​

​

​

​

• Product Management
• Regulatory Affairs
• Pharmaceuticals Sales Representative(PSR)

Scope of Pharmacy:

• Hospital and clinics
• Hospital pharmacists
• Clinical pharmacists
• Community Pharmacy (Retail Pharmacy)
• Wholesale Pharmacy
• Government services
• Regulatory Affairs
• Drug testing laboratories
• Drug purchasing and distribution
• Military services
• Drug Inspector

Drug & Medicine:

• A drug is any substance that acts on living body to alter the physiological process and are used for prevention, treatment and diagnosis of diseases.
• A medicine is any drug which has a definite form and dose and are therapeutically used for the treatment of diseases of living subjects.

​

​

​

Raw Materials

​

• Raw materials are input substances used in both chemical synthesis and processing and include buffers, cleaning agents, common solvents and commonly used synthetic starting materials such as amino acids.
• The pharmaceutical industry makes up one of the largest of chemical industry, so it’s no surprise that there are hundreds of different chemicals and compounds used in it’s production process.

Categories of Raw materials:

• In order to produce quality medicines, a wide range of raw materials must be used by manufacturers. These include powders and liquids from different sources, such as plants, animals, minerals and chemical compounds. The type of material needed for a particular drug depends on its purpose.
• Most chemicals that form part of medications are derived from petroleum or natural gas deposits. For example, active ingredients found in painkillers may include morphine (extracted from poppy seeds),aspirin (from white willow bark) or acetaminophen(from coal tar). By far, most active pharmaceutical ingredients (APIs) come from plant sources; around 40 percent originate from woody plants while 35 percent comes from trees and shrubs. The remaining25 percent is derived mainly from vegetables.

• There are many categories of medicinal chemicals that could be important to today's pharmaceutical industry. They include but aren't limited to: Antibiotics, analgesics, anti-infective, anti-histamines, anti-inflammatory drugs, anticoagulants (blood thinners), cardiovascular drugs such as beta blockers and calcium channel blockers (for high blood pressure), central nervous system drugs such as antipsychotics and antidepressants.
• Coating agents protect drugs from degradation due to moisture loss, oxidation or other environmental factors; some act as preservatives for extended shelf life. Finally, solvents dissolve ingredients into solutions for easier processing during manufacturing. They also serve as vehicles for getting drugs into solution prior to final formulation into solid dosage forms such as pills or liquid suspensions/emulsions.

Threat from Counterfeit Products:

Counterfeit drugs, usually contain low-quality APIs, wrong ingredient, or even the incorrect

Dosages.

Pharmaceutical raw materials manufacturers will be negatively affected by such acts.

​

Raw material departments:

• Purchase and receiving of raw materials
• Storing of raw materials
• Appropriate storage condition

Reference: Pharmaceutical raw materials and excipient analysis for raw materials

​

Quality Assurance

• What is QA?

Quality assurance (QA) is an essential department in the pharmaceutical industry that ensures the safety, efficacy, and quality of drug products for public release. The QA department is responsible for evaluating the product development processes in the research, development, and manufacturing stages.

• Elements of QA System:

Following are the major elements of QA System :

• Inventory Agency

The inventory agency is responsible for coordinating QA\QC activities for the national inventory. The inventory agency may designate responsibilities for implementing and documenting these QA/QC procedures to other agencies or organizations. It must ensure that all other organizations are following applicable QA/QC procedures.

​

• QA/QC Plan:

The QA/QC plan is an internal document to organize, plan, and implement QA/QC activities. Once developed, it can be referenced and used in subsequent inventory preparation, or modified as appropriate (i.e. when changes in processes occur or on advice of independent reviewers).This plan should be available for external review.

• QA Procedures:

QA-Quality assurance department Then assure the quality of material. They are inspector. They take sample from raw material. And transfer this material to QC.. QA inspector may Also inspect and take from any section of production dept. QA allow and check. First, it check and give permission. They perform in process quality test. After completion of manufacturing process quality C test is performed if they fail, they aren’t packed; If pass then packed. They return the report to QA for analysis.

• Quality Assurance Review Process:

The QAR process ensures that a comprehensive review is carried out in accordance with international standards. Generally, it involves the standard four phases i.e. planning, conducting, reporting, and follow-up.

• Quality Assurance in regulatory affairs of Pharmaceutical industry:

Regulatory affairs particularly deal with the regulatory aspect of a medication and pharmaceutical industry thus in the regulation aspect also QA documentation in order to obtain clearance on any related regulatory issues.

• CONCLUSION:

As a conclusion on the entire discussion, it clearly shows that quality assurance is somehow related to all the departments in a pharmaceutical industry, and it plays an important role in each department to enhance the process of that particular department. As how the title mentions that the quality assurance plays vital role and it is said as the backbone of a pharmaceutical industry. Quality Assurance they emphasize on customers satisfaction and also based on the guidelines which have been set up by the authorities.

​

Reference:

Quality assurance for pharmaceutics

​

Quality Control�Production Department

Quality Control

• Industry🡺 to ensure compliance with government regulations and internal policies and with their own procedure, has developed very sophisticated Quality Organization with well defined responsibilities. QA and QC are the part of Quality Unit but have different functions.
• QC department identified in 21 CFR. It’s Function to test and measure material and product. QC department is called the back-bone of Pharmaceutical Industry.
• t is responsible for day-to-day Quality control.
• For sampling and analytical testing of incoming raw material.
• Inspection of Packaging component and labeling. For monitoring product Quality through distribution and evaluating product stability.
• QC plays important role in selection & Qualification of vendors from whom these materials are purchased.
• Responsible for monitoring environmental conditions under which products are manufactured.
• Heads check reports of testing - and reject or accept the process and give final report to QA inspectors.

Production Department

• Production Department is the department which directly involves in manufacturing products. Examples are the machining, finishing, and assembling departments.
• Functions of Production Department :

Production is the functional area responsible for turning inputs into finished outputs through a series of production processes. The Production Manager is responsible for making sure that raw materials are provided and made into finished goods effectively. He must make sure that work is carried out smoothly, and must supervise procedures for making work more efficient and more enjoyable.

Five Production sub-functions:

In a company the Production function may be split into five sub-functions:

​

• The Production and Planning department will set standards and targets for each section of the production process. The quantity and quality of products coming off a production line will be closely monitored. In businesses focusing on lean production quality will be monitored by all employees at every stage.
• The Purchasing department will be responsible for providing the materials, components and equipment required to keep the production process running smoothly. A vital aspect of this role is ensuring stocks arrive on time and to the right quality.
• The Stores department will be responsible for stocking all the necessary tools, spares, raw materials and equipment required to service the manufacturing process. Where sourcing is unreliable, buffer stocks will need to be kept and the use of computerized stock control systems helps keep stocks at a minimal.
• The Design and Technical support department will be responsible for researching new products or modifications to existing ones, estimating costs for producing in different quantities and by using different methods. It will also be responsible for the design and testing of new product processes and product types, together with the development of prototypes through to the final product. The Technical support department may also be responsible for work study and suggestions as to how working practices can be improved.

• The Operations department will be concerned with the manufacture of products. This will include the maintenance of the production line and other necessary repairs. The works department may also have responsibility for quality control and inspection.
• Outputs refer to a finished product or service and inputs are the materials that are needed to manufacture certain goods. When a business completes this process they are able to achieve customer satisfaction by producing products that are ready to be used and fit for purpose.

Reference:

Remington

​

Different sectors of Production Department:

Sterile Area�Packaging Department�Marketing department�Research and development department

Sterile Area

• What is sterile area in pharmaceutical industry?

Sterile pharmaceutical controlled rooms are clean rooms that are fitted with HEPA(high efficiency particulate air)filters, and dehumidifier systems to allow preparation of pharmaceutical products in a moisture- free and contamination-free environments.

• What pharmaceutical products are sterile?

Injections, ophthalmic preparations, irrigation fluids, dialysis solutions, sutures and ligatures, implants, and certain surgical dressings, as well as instruments necessary for their use or administration, must be presented in a sterile condition.

• What is the difference between sterile and aseptic technique?

Aseptic and sterile go hand in hand. Aseptic means something has been made contamination-free, that it will not reproduce or create any kind of harmful living microorganisms (bacteria, viruses and others). Sterile describes a product that is entirely free of all germs.

​

​

• How are pharmaceuticals sterilized?

Thermal sterilization is the most commonly used sterilization method in the pharmaceutical and biotechnology industries. Industrial radiation sterilization processes utilize electron beams, gamma rays, or X-rays.

• What is Grade A area in pharmaceutical industry?

For the manufacture of sterile pharmaceutical preparations, four grades of clean areas are distinguished as follows: Grade A: The local zone for high-risk operations, e.g. filling and making aseptic connections. Normally such conditions are achieved by using a unidirectional airflow workstation.

• What do you mean by non-sterile manufacturing?

Non-sterile compounding involves creating a medication in a clean environment but does not require the environment to be completely free from all microorganisms.

• What is the difference between steam sterilizer and autoclave?

While autoclaves solely utilize steam to disinfect, sterilizers can use chemicals, high pressure, filtration, irritation, or a combination of these methods to eliminate living organisms.

• Why do we sterilize pharmaceutical products?

To ensure patient safety, parenteral/injectable drug products must be sterilized to destroy any potential microbial contaminants (fungi, bacteria).

​

• Recent years have shown steady growth in manufacturing sterile, high potent products in the pharmaceutical industry. Antibiotics for intravenous or intramuscular injection in powder form such as Ceftriaxone Sodium for example, need to be produced under sterile conditions.
• Terminal sterilization is the preferred method for drug products because, in this process, sterilization takes place after the product has been filled into the primary packaging.
• Why do we need sterile filtration for biologic drugs?
• Sterilization methods using high heat or radiation will, for instance, cause degradation of most biologic drug substances. For biopharmaceutical products, therefore, sterile filtration under aseptic conditions is required. Small-molecule APIs may also be sensitive to heat or radiation.
• Do you need terminal sterilization for Parenteral drugs? Parenteral products must undergo some form of sterilization, and terminal sterilization is generally the preferred method. Because sterile products manufacturing requires specialized expertise, many pharmaceutical companies rely on contract service providers.

Reference:

WHO good manufacturing practices for sterile pharmaceutical products

Packaging Department

• Pharmaceuticals require more detailed packaging than do other sensitive products, such as foods, although there are several similarities in their requirements. Security and integrity of the package are, however, more important and are controlled by licensing arrangements. This is performed by packaging department.
• Guidelines on Packaging for Pharmaceutical Products:
• All medicinal products need to be protected and consequently need to be packaged in containers that conform to prescribed standards, particularly with respect to the exclusion of moisture and light and the prevention of leaching of extractable substances into the contents and of chemical interaction with the contents.

​

The packaging protects against all adverse external influences that can alter the properties of the product, e.g. moisture, light, oxygen and temperature variations

• protect against biological contamination;- protect against physical damage

carry the correct information and identification of the product. The kind of packaging and the materials used must be chosen in such a way that

• the packaging itself does not have an adverse effect on the product (e.g. through chemical reactions, leaching of packaging materials or absorption)
• the product does not have an adverse effect on the packaging, changing its properties or affecting its protective function.

Types of Containers:

• Ampoule:

container sealed by fusion and to be opened exclusively by breaking. The contents are intended for use on one occasion only.

• Bag:

A container consisting of surfaces, whether or not with a flat bottom, made of flexible material, closed at the bottom and at the sides by sealing; the top may be closed by fusion of the material, depending on the intended use.

• Blister:

A multi-dose container consisting of two layers, of which one is shaped to contain the individual doses. Strips are excluded.

• Bottle:

A container with a more or less pronounced neck and usually a flat bottom.

• Cartridge:

A container, usually cylindrical, suitable for liquid or solid pharmaceutical dosage forms; generally for use in a specially designed apparatus (e.g. a prefilled syringe).

• Gas Cylinder:

A container, usually cylindrical, suitable for compressed, liquefied or dissolved gas, fitted with a device to regulate the spontaneous outflow of gas at atmospheric pressure and room temperature.

• Injection Needle:

A hollow needle with a locking device intended for the administration of liquid pharmaceutical dosage forms.

• Injection Syringe:

A cylindrical device with a cannula-like nozzle, with or without a fixed needle and a movable piston, used for the administration, usually parenteral, of an accurately measured quantity of a liquid pharmaceutical form. The syringe may be prefilled, and can be for single-dose or multi-dose use.

Instructions for packaging material:

• a description of its pharmaceutical form, strength and, where applicable, method of application

​

• the pack size expressed in terms of the number, weight or volume of the product in the final container

• a complete list of all the packaging materials required for a standard batch size, including quantities, sizes and types, with the code or reference number relating to the specifications for each packaging material

• where appropriate, an example or reproduction of the relevant printed packaging materials and specimens, indicating where the batch number and expiry date of the product have been marked

• Special precautions to be observed, including a careful examination of the packaging area and equipment in order to ascertain the line clearance before and after packaging operations.

Reference:

Pharmaceutical packaging Handbook by Edward Bauer

Marketing Department:

Pharmaceutical marketing is a critical aspect of the pharmaceutical industry. It involves the design, production, and evaluation of marketing materials and strategies for pharmaceutical products . Pharmaceutical companies rely heavily on marketing to reach physicians, clinicians, and consumers . Companies recognize the importance of product marketing for success in the pharma sector.

Role of Marketing Department:

• Sale of the product
• Advertisement of the product
• Name of the product
• Design of the Packaging material
• Price of the Product (Approval of price)
• Conduction of seminar conferences
• Training of the sails person
• Distribution of the product in market
• Outdoor works of organization except legislation

Reference:

​

“Marketing Department: How to successfully Market in the Pharma Industry” by Colormatics

​

Research and development department:

Research and development (R&D) is a critical function of the pharmaceutical industry . It involves the discovery, development, and testing of new drugs and therapies . The R&D department is responsible for identifying new drug targets, developing new drugs, and conducting clinical trials to test the safety and efficacy of new drugs . The R&D process is complex and can take many years to complete.

​

Role:

• In order to make new DDS drugs (improvement)
• For innovation in new DDS, drugs
• To solve the problem of existing dosage form
• Any compound/drug in your hand has at least 10 years travelling. Many compounds are researched, synthesized and isolated but only few of them become successful for drugs

​

Reference:

​

“Pharmaceutical Research and Development: A Guide to Good Practice” by J. Rick Turner

​

​

Forensic Pharmacy �Hospital pharmacy

Forensic Pharmacy

• Forensic is derived from Latin word "Forensis” means “In open court or public"
• The branch of pharmacy that deals with the study of drugs/medicines laws is known as forensic Pharmacy.
• Basically, it is the use of:
• Scientific Knowledge to detect crimes
• Enrollment of pharmacy in the detection of crime.
• It deals with the application of the science of drug to legal issues.
• Duties and responsibilities of all government authorities.

Such as Including the pharmacy education system, etc

• How to register ne new drug industry or institute
• How to obtain License to manufacture and sale drugs/medicines.
• All the professional duties are performed according to the drug laws. Drug courts and Drug inspectors make sure that these rules are followed or not. If someone violates the it would be considered a crime. They control rules and regulations of drug marketing. These rules and regulations are handled under drug acts/laws.

​

Pharmacy History

ACT, 1967

Pharmacy council of Pakistan was established Under Pharmacy Act, 1967.

• They are controlling and governing pharmacy education.
• Also responsible of pharmacist and fore registrations pharmacy technicians. All types of matters related to drugs are studied under this act like:
• Manufacturing
• Pricing sales
• Import
• Export
• In 2007, some amendments are amendments in drug Act:

Life saving medicines will only be present at pharmacy and sold the vision of pharmacist, Under Drug Act, 2012. An Act to provide for the establishment of DRAP (Drag regulator authority of Pakistan).

Hospital Pharmacy

Hospital deals with procurement, storage, compounding, dispensing, manufacturing, testing, packaging, distribution of drugs along with research in pharmaceutical Sciences. Either be private / public sector. Functions:

• Dispensing:
• outdoor patients
• Indoor patients
• Medical, surgical laboratory supplies
• Alcohols
• Statics and Report
• Inventory control and Record
• Teaching: To train new internship's pharmacist
• Research (Drug Information Centre)
• Manufacturing, Labeling and storage Large volume

Objectives and location

Objectives:

• Create professional and positive behavior with para-medical staff.
• Participate in new researches and development.
• Hospital formulary: lists of medicine prepared according to need of patient.

Location:

• It should be at ground floor so that all patients(indoor+outdoor) can easily get the medicines.
• A pharmacist should always be available at pharmacy because in case of any emergency he/she can help.

Reference: Textbook of Forensic Pharmacy by Bhaskar Chaurasia and Rajiv Kumar Chaurasia

Clinical Pharmacist�Poison Control Center�Drug Information Center�Drug Testing Labs�Drug Court

Clinical Pharmacy

• Definition:

Clinical pharmacy is a branch of pharmacy that involves the provision of patient care with the use of medications to optimize the health outcomes of patients.

• Clinical Pharmacist:

Clinical pharmacists are responsible and accountable for medication therapy and patient outcomes.

• Clinical Pharmacist’s role:
• Within the system of health care, clinical pharmacists are experts in the therapeutic use of medications. They routinely provide medication therapy evaluations.
• Clinical pharmacists are a primary source of scientifically valid information and advice regarding the safe, appropriate.
• However, clinical pharmacists are making themselves available through a medication information hotline.

The 6 Rights of Medication Administration:

• Right Patient

• Right Drug

• Right Dosage

• Right Route

• Right Time

• Right Documentation

POISON:

Human poisoning subsumes any toxin-related injury.

The injury can be systemic or organ-specific (e.g., neurological injury or hepatotoxicity).

The source of the toxin can be a synthetic chemical or a naturally occurring plant, animal, or mineral substance.

Poisoning can include the toxic effects of a classic toxin (e.g., cyanide), an overdose of a prescription medication (e.g., an antidepressant), an overdose of an over-the-counter preparation (e.g., headache tablets), or a complementary treatment (such as an herbal medicine or dietary supplement).

Poison Control Centers:

Poison control centers are essential components and building blocks of a poison prevention and control system.

Role:

1. These centers are on the frontline of meeting the needs of the public and the health care community for information and guidance concerning poison exposures.

​

2. The poison control centers serve a vital public health function, accentuated by the public concerns about exposure to biological and chemical agents of terrorism.

In the future, however, the poison control centers must be more stable financially, population based and better integrated and coordinated with other stakeholders involved in the protection of the public from hazardous substances.

Reference: Forging a poison prevention and control system

​

Drug Courts:

Drug courts are specialized court docket programs that target criminal defendants, juveniles who have been convicted of a drug offense, and parents with pending child welfare cases who have alcohol and other drug dependency problems.

​

Role:

Although drug courts vary in target population, program design, and service resources, they are generally based on a comprehensive model involving:

1. Screening and assessment of risks, needs, and responsivity.
2. Judicial interaction.
3. Monitoring (e.g., drug testing) and supervision.
4. Graduated sanctions and incentives.
5. Treatment and rehabilitation services.

​

​

Management:

Drug courts are usually managed by a non-adversarial and multidisciplinary team including judges, prosecutors, defense attorneys, community corrections, social workers and treatment service professionals.

Reference: National Institute of Justice (NIJ)

​

Drug Information Centers:

• Drug information centers were established in the mid-1960s, and they are staffed by pharmacists who review, collect, organize, and analyze drug information and disseminate it to health-care professionals and consumers.
• Drug information centers or services often exist as functioning departments within health-care institutions, within the pharmaceutical industry, in academic settings, or as independent centers serving health-care professionals and the public.
• The activities of drug information centers or services have increased dramatically since they were first established.
• Drug information centers or services are an excellent resource for health-care practitioners when assistance is required in handling a difficult clinical problem or when significant time or resource constraints exist.

​

Drug Testing Labs:

Drug testing labs are specialized facilities that provide testing services for drugs and other substances . They are staffed by trained healthcare professionals who are available to perform a variety of tests, including drug screening, drug confirmation, and drug quantification . Drug testing labs also provide information on the safe use and storage of medications and other household products.

Importance:

• Drug testing labs are specialized facilities that provide testing services for drugs and other substances.
•  They are staffed by trained healthcare professionals who are available to perform a variety of tests, including drug screening, drug confirmation, and drug quantification.
•  Drug testing labs also provide information on the safe use and storage of medications and other household products .
• The importance of drug testing labs lies in their ability to ensure the safety and efficacy of pharmaceutical products.
•  Drug testing labs play a critical role in the development and testing of new drugs and therapies, ensuring that they meet regulatory requirements and are safe for human use.
•  They also play a vital role in monitoring the quality of existing drugs and ensuring that they remain safe and effective over time. 
• Drug testing labs are essential for maintaining the integrity of the pharmaceutical industry and ensuring that patients receive the best possible care.

​

​

​

Role of drug inspector:

• A drug inspector is a professional who is an expert to monitor the safety, utility efficiency, and quality of a drug from its manufacturing until its sale at the retail shop.
• A drug inspector or quality control inspector is the one who works to ensure that the drugs are safe for human consumption.
• Their primary responsibility is to examine pharmaceuticals at varying stages of the manufacturing, distribution, and selling process to ensure that the prescribed standards are being met.

References:

American College of Clinical Pharmacy (June 2008).

"The definition of clinical pharmacy" (PDF).

Pharmacotherapy. 28

Remington

“Analytical Testing for the Pharmaceutical GMP Laboratory” by Kim Huynh-Ba

“Drug Inspector Exam: Complete Guide” by Dr. Sanjay Gupta 

The End �