Table 2 Factor analysis of the Lebanese Industry pharmacist competencies’ (Varimax rotated component matrix)

Domain 0: research and development

1

Implement experimental conditions for synthesizing a chemical entity

2

Organize a scientific monitoring process

3

Implement experimentation protocols to characterize the interaction target-molecules

4

Design and validate a technique for obtaining or characterizing a molecule

5

Use a technique for extraction and purification of a natural origin molecule

6

Use molecule characterization techniques (separation techniques, spectroscopic techniques, capillary electrophoresis, etc.)

7

Use a technique for gene expression

8

Integrate the input requirements and objectives of the process

9

Identify the different phases of a research process

Domain 1: pharmaceutical and industrial development

1

Develop formulations for different routes of administration (including controlled and modified release systems) according to the characteristics of the molecules and the marketing objectives

2

Demonstrate the ability to perform pharmaceutical calculations accurately

3

Design and implement improvements in the formulation development techniques

4

Analyze the economic feasibility of a formulation and industrial development plan

5

Set a process to optimize a formulation

6

Apply the established physicochemical characteristics of active molecules, using appropriate analytical techniques (X-ray diffraction, DSC, solubility, etc.)

7

Apply pharmaceutical knowledge to select appropriate ingredients and excipients of the required quality standard for the manufacture and compounding of medicines

8

Stay up to date with all activities and innovations related to industrial pharmacy

9

Use experimental designs to master the process (e.g., factorial design)

10

Translate test results into instructions and procedures

11

Evaluate the feasibility, reliability, and reproducibility of a method or equipment, and implement the concept of risk management

12

Elaborate the product characteristics through the test results by integrating the regulatory and commercial data

13

Elaborate packaging characteristics appropriate to the container content, avoiding in vitro interactions and maintaining physicochemical stability

14

Develop packaging characteristics from the properties of the molecules and the developed dosage form

15

Demonstrate an understanding of the legislative framework and requirements that govern the manufacture of medicinal products, including GMP

Domain 2: analytical development

1

Design and implement improvements in analytical development techniques

2

Implement analytical tests (molecules, impurities, and end-product) and dosing techniques using protocols

3

Evaluate the feasibility, reliability, and reproducibility of an analysis by integrating the concept of risk management and analytical validation

4

Identify the physicochemical variables to point to an analytical technique of a molecule, impurities, and end-product

5

Translate test results into instructions and procedures

6

Set an experimental context to point to an analytical, separation, or dosing technique, depending on the characteristics of the formulation, and regulatory and commercial constraints

7

Analyze the economic feasibility of an analytical development project

Domain 4: industrial pharmaceutical production

1

Design a validation protocol of manufacturing and packaging processes

2

Determine the follow-up and control setup according to these results

3

Propose and support technical improvements in production methods and processes according to the follow-up results

4

Identify and assess the conditions of storage, transport, and distribution of products

5

Analyze the expected return of each step and the deviations

6

Use a monitoring statistical process control (MSP) tool and interpret results to analyze the capability and robustness of processes and identify areas for improvement

7

Use production management tools

8

Organize and plan various activities of production in compliance with regulations, quality, hygiene and safety rules, cost, and defined deadlines

9

Analyze critical steps of manufacturing and packaging processes

10

Organize and control the movement of products as well as documentary flows

11

Analyze the critical specific steps of the biotechnology products processes

12

Establish continuous improvement conditions and follow-up the improvement of the industrial processes

13

Propose and implement corrective actions to reduce costs and delays in conjunction with other departments and evaluate the results

14

Use methods to improve production organization

15

Define and implement tracking indicators of the activity of a department and productivity indicators

16

Analyze the results of production and productivity monitoring indicators

17

Optimize the organization of work, work processes, and means

18

Deploy a system of environmental risk management (an ISO 14001 type) and make it live alongside the other management systems (quality or other)

19

Animate an action plan within a team

Domain 4: quality assurance and control

1

Define and organize batch stability monitoring

2

Estimate the authenticity of the results to generate the certificate of analysis

3

Analyze the causes of non-compliance related to quality and safety

4

Suggest and implement corrective actions to address the non-compliance related to quality and safety in conjunction with other departments

5

Implement the analysis (quality control of raw material, finished or semi-finished products), interpret and validate the results

6

Define sampling plans and compliance

7

Analyze the causes of a malfunction, drift, or non-compliance related to a process or equipment, and identify corrective measures

8

Identify and assess the constitution of the sample library

9

Assess the compliance with standards of a batch record

10

Assess the compliance of batches from the analytical and manufacturing files

11

Identify maintenance operation of manufacturing and quality control equipment

12

Assess the compliance of activities, premises/facilities and equipment with the quality standards (GMP, ISO), and safety rules

Domain 5: quality management

1

Organize and manage the traceability of all industrial operations (archiving procedures, electronic document management systems)

2

Organize and document annual reviews

3

Implement a global quality approach including the concepts of quality control, quality assurance, and quality management

4

Develop and implement general and transversal quality systems deployed in all business sectors: research, development, production, distribution, marketing, promotion, information, operations, etc

5

Define the conditions of the customer–supplier relationship and establish the quality aspect in its implementation

6

Design procedures for complaints handling, batch follow-up, batch recalls, and traceability

7

Understand the principles of pharmacoeconomic assessment and medicines cost–benefits analysis

8

Demonstrate the ability to analyze and manage financial data and budgetary information effectively

9

Analyze the costs of non-quality

10

Use risk management methods: define risks and hazards, identify critical points, and design approaches that put them under control

11

Integrate environmental risk management in the Quality Management System

12

Define the quality policy elements of the company

13

Design a procedure for process validation and equipment qualification

14

Define a method of audit, an audit program: achieve audits and make audit follow-up

15

Develop, implement, and evaluate quality training programs

Domain 6: pharmacist preparedness and response in emergency situations

1

Ensure medication delivery/safe storage

2

Develop workplace training and safety protocols (e.g., social distancing)

3

Secure PPEs or other needed materials

4

Procure essential medications and supplies

5

Monitor workers/assistants for symptoms

6

Adapt working hours to meet essential services during crises

7

Participate in interdisciplinary training to EPR teams

8

Publish and/or disseminate findings

9

Participate in research and studies on EPR

10

Balance stockpile and availability of drugs for existing/chronic conditions

11

Develop training programs for peers and other healthcare workers

12

Check for volunteering opportunities

13

Combat misinformation by disseminating evidence-based information to patients and sharing it on social media

14

Check for training opportunities

15

Address medication shortage and mitigation plan

16

Secure sanitizers and other medications when needed

17

Follow actions and recommendations of local authorities

18

Check for FDA/EMA Emergency Use Authorizations (EUAs) and expedited review and approval of tests/drugs for treatment

19

Involve trainees and staff in emergency response

20

Partner with local authorities

21

Identify at-risk populations

22

Answer EPR-related calls

23

Manage panic buying