Study Protocol: Central Elements

Protocol is an established code of procedures.

A protocol defines a set of operational procedures to ensure that there is a well- defined way of doing a particular task or range of tasks (often informed by past experience). Protocol is a “road map” for the research project/work.

It is a predefined written procedural method in the design and implementation of experiments. It is an exploratory document with a defined plan and shall clearly spells out why you are doing the research, what the research question and data needed to answer the question are, and how to gather and analyze the data.

In most cases it is a formal agreement and commitment between two or more parties on a common response to specified issues, events or circumstances e.g. information sharing.

Protocol should stand on its own, and refrain from referring to multiple documents for execution of the activity. Protocols are written whenever it is desirable to standardize a laboratory method to ensure successful replication (reproducibility) of results by others in the same laboratory or by other laboratories. Detailed protocols also facilitate the assessment of results through peer review. Protocols are employed in a wide range of experimental fields.

The central elements of protocol include:

·         Study rationale with background

·         Study objective(s)

·         Study Design (organization of experiment) and methodology

·         Required equipment and instruments

·         Safety precautions

·         Detailed procedures/methods

·         Study population/samples

·         Study time frame (Duration)

·         Calculation of results and reporting standards

·         Statistical considerations

·         Rules for predefining and documenting excluded data to avoid bias.

·         Accepted outcome/acceptance criteria

Protocol differ from SOP in being more elaborate; provide background & rationale for exploratory study with objectives and at times acts as an agreement between two or more parties/stakeholders (multi center studies). Protocol is often employed for a one time study. On the other hand the SOP provides a set of systematically written instructions to ensure that a task is performed same way each time.

Competence, Awareness and Training

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1. Purpose:
· To ensure that the personnel performing work affecting quality is competent on the basis of education, training, skills and experience.
· To identify personnel training needs, provides required training, and evaluates the effectiveness of the training provided.
· To make employees aware of the relevance and importance of their activities and how they contribute to the achievement of quality objectives.
· To maintain records of personnel qualifications and training are maintained.

2. Scope:
This SOP is applicable for all the employees’ working in xxxx (Company Name).

3. Responsibility:
Department                             Responsibility

Departmental Head: Responsible for identifying training needs and awareness programs for company-wide participation, such as: general orientation, rules and regulations, quality system, safety, and other company-wide systems and issues.
Process Leads: Responsible for identifying competency requirements and training needs in their departments, and for requesting departmental training sessions. Departmental training is primarily focused on increasing the level of skills in operating equipment and processes. Operational Managers and Supervisors are responsible for coordinating with the Administration Department in relation to any training activities.
Training Department: Responsible for maintaining centralized training records for each employee and for supplying this information to Department Managers and Supervisors as required.

4. Abbreviations:
RF: Record Form

5. Definitions
NA

6. Procedure:

6.1 In xxxx (Company Name) job responsibility have been identified and prepared to ensure the competency of personnel whose work affects the conformity to product/services requirements. Competency Matrix identifying the qualifications required for each position, including education, skills and experience requirements, along with the training required to provide the competence required for each position.
(1: Job Responsibility).

6.2 Competence:

6.2.1 Employee qualifications are reviewed upon hire, when changing positions or when the requirements for a position change.
6.2.2 Each process lead shall identify the competency needs for personnel within their department performing activities affecting conformity to product requirements.
6.2.3 Managers shall evaluate employees under their direction to determine competency gaps.
6.2.4 If differences between the employee’s qualifications and the job requirements are found, training or other action is taken, where applicable, to provide the employee with the necessary competence for the job.
(2: Competency Matrix)

6.3 Types of Training: Following are the training performed by xxxx (Company Name).

6.3.1 Induction/General orientation and quality system awareness training: Explains how xxxx(company name) services are used in the different industries and how the quality system works to ensure process quality. Introduces employee to organization's internal structure. Provided to all employees.
6.3.2 Document Training: The newly joined employee shall be given the job function training as per the job description before he takes on the change of his post. Generally the training includes introduction to the Quality Management System (QMS), job responsibilities, reporting pattern, and procedural training.
6.3.3 cGMP Training: Current trends in Good Manufacturing Practices as per Schedule M of Drug and Cosmetic Act (1940, 1945) of India, WHO cGMP guidelines and other statutory and regulatory requirements and international guidelines relevant to the scope of work.
6.3.4 External training: External seminars, conferences, and courses. Provided to individual employees on as-need basis.
6.3.5 Skill training: Training in specific skills as per the requirement of the Project or function assigned to the employee. Often provided as special training, hands on and skill level training.
6.3.6 Self-study: Reading training manuals, magazines, books, and reports. While all employees are encouraged to broaden their knowledge through reading, in some cases self-studying may be required as formal training.
6.3.7 Remedial training/ Retraining: in case of evidence that the original training was not adequate to a person who could not perform efficiently; a deviation; out of specification result; accident or as a result of regulatory audit observations.
6.3.8 Temporary employee and contractor training include training on fundamental cGMPs and specific training on duties assigned.

6.4 Induction Procedure:

6.4.1 HR shall extend a warm welcome to the newly appointed staff and give a brief description of the company.
6.4.2 HR shall get completed all the requirements as per the company’s policy in respect of newly appointed staff.
6.4.3 Shall provide the new joinee with the induction program which after completion of the induction shall be submitted to the HR.
6.4.4 Introduce the newly appointed staff with relevant key members of the company with whom the staff shall directly or indirectly interact during their normal course of work.
6.4.5 Inform staff of the concerned department about arrival of the newly appointed staff in advance.
6.4.6 Brief the newly appointed staff about the company, its policies and practices.
6.4.7 Accompany the newly appointed staff to his / her department of placement.
6.4.8 The Head of the concerned department shall welcome the newly appointed staff and explain:
· About the functions / roles of the department.
· Job descriptions of the newly appointed staff.
· Shall explain the type and nature of the work that have to be performed.
· Gives introduction to GMP and related functions
· Provide them with sitting place and day to day use stationery items.
· Shall introduce the newly appointed staff to other colleagues in the department.
· Shall appoint a mentor to guide the new employee during his first few weeks in office.
6.4.9 After induction period is over the employee is placed in training period and shall be trained in all the job functions he or she will perform. The employee is requested to fill induction feedback form.
(3: Induction record)
(4: Induction Feed Back)

6.5 Job function training:

6.5.1 It is the responsibility of the departmental head to provide the job function training of the newly joined staff. No employee shall be given charge of his functions unless his job function training is complete.
6.5.2 The training includes introduction to Quality Management System (QMS), job responsibilities, reporting pattern, and procedural training.
6.5.3 After the Job function training is over the training record form shall be filled and submitted to HR department to be attached to the employee training file.
6.5.4 Whenever the Job responsibility of the employee is changed, revised due to transfer, new job assignment etc the employee shall be trained as per the new job requirement and the updated training record shall be submitted to the HR department to be attached in the employee training file and one copy is also with the employee.

6.6 cGMP Training

6.6.1 All the employees who have the technical responsibility shall be trained for Current trends in Good Manufacturing Practices as per Schedule M of Drug and Cosmetic Act (1940, 1945) of India, WHO cGMP guidelines and other statutory and regulatory requirements and international guidelines relevant to the scope of work.
6.6.2 These trainings shall be provided at regular interval to keep them updated in the field. The record of these trainings shall be kept and submitted to the HR department to be attached in the employee training file.

6.7 External training: External seminars, conferences, and courses. Provided to individual employees on as-need basis. The records of these trainings shall be maintained in HR department in the employee training file.

6.8 Skill training: Training in specific skills as per the requirement of the Project or function assigned to the employee. Often provided as special training, hands on and skill level training. If available the records of these trainings shall also be maintained.

6.9 Self-study: Reading training manuals, magazines, books, and reports. While all employees are encouraged to broaden their knowledge through reading, in some cases self-studying may be required as formal training.

6.10 Remedial training/ Retraining: in case of evidence that the original training was not adequate to a person who could not perform efficiently; a deviation; out of specification result; accident or as a result of regulatory audit observations.

6.11 Temporary employee and contractor training include training on fundamental cGMPs and specific training on duties assigned.

6.12 Training Need Assessment:

6.12.1 Organizational training needs: The focus shall be on organizational goals, departmental performance issues and future development needs.
6.12.2 Job related training needs: Job/Task related training needs shall be identified to analyze the role that employees have to play in the organization. Assigned job training needs assessment shall focus on the job characteristics and improvement of current skill levels required by the employees to perform their present job according to identified performance parameters.
6.12.3 Personnel Training Needs: Training needs assessment at personnel level shall focus on the current knowledge levels or performance parameters and expected future responsibility.
(5: Training Calendar)

6.13 Conducting Training:

6.13.1 For Conducting an effective training session the following logistical arrangements shall be considered before training is imparted:
· Suitable training venues (well-lit and well-ventilated with adequate space away from source(s) of noise.
· Preparation of training agenda and circular to notify the trainees and HODs of the dates, time and location of training.
· Preparation of instructional materials including the Student materials like texts, handouts, assignments, computer-based materials and instructional 3aide like audiovisual materials, models, demonstration equipment.
· Arrangement for appropriate training equipment (may include microphone, whiteboard and marker, flipchart paper, writing materials, slide and/or overhead projector, LCD projector and computer, video equipment, screen etc.).
· Arrangement of training room, seating arrangements, name cards (if required), position of whiteboard, screen, etc.
· Arrangement of tea/coffee and meal breaks during course.
· Arrangement of transportation/accommodation as needed for outside speakers/trainers.
(6: Training Agenda)

6.14 Evaluation of Training

6.14.1 Trainee Evaluation:
· Trainees shall be evaluated to assess the transfer of knowledge by various evaluation methods like -written tests (multiple choice, true/false, descriptive etc.) demonstrations and performance checklist, problem solving, or interviews, (verbal evaluation).
· These training methods may be used for pre-training, on-going, post-training or follow up evaluation as deemed fit by the trainer.
· The trainer shall select appropriate evaluation method to evaluate trainee performance.
· The criteria for evaluation or assessment and pass percentage shall also be decided by the trainer and shall be documented in Training Program Overview.
6.14.2 Evaluation of trainer and the training program:
· The trainees shall be provided with Course Evaluation Form to evaluate the effectiveness of training and the performance of the trainer.
· The feedback forms shall be reviewed by training section, QA Department to find out whether the course objectives were achieved and also in improving the efficiency of training.
(7: Training Attendance Sheet)
(8: Training Evaluation Sheet)
(9: Training Questionnaire)
(10: Training Feedback)

7. ReportingAnnexure 1 to 10

8. Annexure:
Annexure No: Title

1. Job Responsibility (Template)
2. Competency Matrix (Template)
3. Induction record
4. Induction Feed Back
5. Training Calendar (Template)
6. Training Agenda (Template)
7. Training Attendance Sheet
8. Training Evaluation Sheet
9. Training Questionnaire (Template)
10. Training Feedback

9. References:
9.1 ISO 9001:2008- Quality Management System-Requirements.
9.2 ISO/TR 10013: Guidelines for quality management system documentation.

10. Distribution:
Master Copy: Archived at Quality Department
Controlled Copy 1: Administration Department
Subsequent Controlled Copy: Department making request

11. History:
Revision Number:           Change Summary
00:                                  None

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SOP QA002: Control of Documents

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	1			Purpose:
				To lay down the procedure for distribution, control, archival and destruction of the documents.
	2			Scope:
				This procedure is applicable for all the documents, which relate to the quality system, manufacturing, testing and control, including documents of external origin used in xxxx (Company Name)
	3			Responsibility:
				Department						Responsibility
				Quality Department						Control, archival, issue, distribution, and destruction of the all the documents used in xxx (Company Name)
				User						Responsible for maintaining the integrity of the document (i.e., the document shall be legible and identifiable).
	4			Abbreviations:
				QA				Quality Assurance
				RF				Record Form
	5			Definitions:
				Same as in SOP for SOP
		6		Procedure:
		6.1		A document shall be controlled at all the stages of document life cycle which includes: preparation, review, authorization, training, retrieval and archiving and destruction.
		6.2		Documents include Quality policy, Quality manual, procedures, specifications, protocols, instructions, records, reports and any other document which is used at xxxx (Company Name) for planning, operation and control of processes. This also includes the document of external origin. Note: Documents of external origin includes all the documents used by xxxx (Company Name) for reference or operation within the preview of Quality System. This may include Pharmacopeias, Standards (National/international), Statutory/Government regulations, Customer documents (Procedures, Designs, Drawings & Layouts, Proposals etc.) and any other document which is not the property of xxxx (Company Name) for operation and control of the system.
		6.3		Document can be in any form or type of medium (paper based or digital).
		6.4		Preparation of Document:
		6.4.1		All the documents shall be prepared by the individuals knowledgeable with the activity and the organization's internal structure. These documents shall be reviewed and finally authorized by the person appointed by Management.
		6.4.2		All documents shall be prepared as per the respective SOPs.
6.5			Authorization of Document: All the documents after departmental review shall be reviewed by Quality Department for completeness, suitability and standard/regulatory aspects. Finally the document shall be authorized by Head QA or any other person designated by management. The original signed copy shall be designated as ‘Master Copy’. The distribution of the document shall be controlled and controlled copy shall be a photocopy of the master copy.
6.6			Training of the Document: After the document has been authorized concerned personnel shall be trained for the document and the training record maintained. The training shall be in the form of questionnaire ranging from 5 to 10 questions. The pass marks shall be 80% or more of the total marks. (1. Document Training Questionnaire Format)  (2. Document Training Record Form)
6.7			Implementation of Document: After the successful training has been imparted to concerned personals the document shall be made effective by putting effective and next revision date and considered as Master Copy. Generally, the effective date of the document must be 2-3 days after authorization to give sufficient time for effective training.
6.8			Revision of Document:
6.8.1			All the documents under the umbrella of Quality Management System shall be reviewed periodically for completeness and applicability. When revision is due the QA or any other person appointed by management shall intimate the concerned department. (3. Intimation for Document Review)
6.8.2			The documents which become smeared, dirty or are ragged shall be changed on need basis. Change in the contents of the document or deletion of the document shall be made through change control procedure.
6.8.3			Documents shall be reviewed every two years (± 60 days) for keeping them updated. Training of the document is required after this revision.
6.8.4			In case the change in Documents is sought in less than two years it should be made through request for document change, if only the change does not affect QMS and does not require retraining. Any change requested which is supposed to have effect on the QMS shall be dealt through change control procedure. (4. Request for Document Change)
6.8.5			A brief description of changes made in the Document shall be given under the heading ‘History’ and the revision should reflect in the header of the document under revision number and supersedes.
6.8.6			The changed document shall only be made effective after the previous version of circulated document is retrieved by Quality Assurance Department.
		6.9		Identification of internal document:
		6.9.1		All documents shall be prepared as per the respective SOPs. The templates for writing any other documents such as protocols, reports etc., are annexed to the relevant procedure or work instruction.
		6.9.2		All the procedures are uniquely identified for tractability and control of the document of that category.
		6.10		Mater list:
				Master list of all the document categories (such as Manuals, Procedures, Records, Protocols etc.) shall be prepared and maintained. The master list shall be reviewed periodically. The master list shall be under the control of Quality Assurance Department. (5. Master List of Documents)
		6.11		Control of internal document:
				Distribution and control of the documents of internal origin is maintained as follows:
		6.11.1		Master Copy: All documents shall be authorized before making them effective by the competent authority as assigned by the management. The copy used for authorization shall be printed in black ink. The authorized (originally signed) document shall be stamped in red ink as ‘MASTER COPY’ on the top right corner of the document. Note: All the documents shall be signed in blue ball-pen ink.
				Note: Documents under restricted circulation (if any) shall be stamped as ‘CONFIDENTIAL’ in red ink on the front side of each page at top corner.
		6.11.2		Controlled Copy: The required number of documents shall be copied from the Master Copy and shall be stamped in colored ink (blue ink) as ‘Controlled Copy’ on the lower right corner of the document and distributed as per the distribution list.
				If a copy of the document needs to be distributed for activity/ operation(s)/ practice(s)/ reference, the photocopies of master copy shall be released on request with proper reason duly authorized by person designated by the management under CONTROLLED conditions. The record for distribution detail of the document shall be maintained in the prescribed format. (6. Request for Document) (7. Distribution of Document)
				The controlled copy shall be dated and numbered chronologically.
				Controlled Copy has a retrieval control and shall be retrieved and destroyed before new version is made available.
		6.11.3		Uncontrolled Copy: Uncontrolled documents are current on date of issue but are not covered by change control. Hence, it must be checked by the user for correctness of information as on date. These are the documents which does not have retrieval control, however if any retrieval is encountered the document shall be destroyed. These documents when issued shall be stamped as ‘Uncontrolled Copy’ (in blue ink) on top right corner of the document.
				The issue record shall be maintained in the prescribed format. (7. Distribution of Document)
		6.11.4		Obsolete Copy: The documents, which have been amended or removed from use, are called obsolete. These are removed from controlled circulation and destroyed. Only one copy is preserved for legal and/or knowledge preservation purposes. The master copy of the superseded document shall be maintained in the documentation cell stamped as ‘Obsolete’ in colored ink (red ink) at the center of each page and filed in a separate file (Obsolete File).
		6.12		Control of Record Forms:
		6.12.1		Records forms are the special type of documents which when filled provides evidence to conformity to requirements and of the effective operation of a system.
		6.12.2		Each type of record forms such as Production activity records, Batch Manufacturing Record form, QC Testing Record Forms and Quality Management Record forms are issued by QA department and issue records maintained as per respective SOP.
		6.13		Control of Log Books:
				The routine operation activity shall be logged in a log books and log books shall be issued to all concerned departments and controlled as per respective SOP.
		6.14		Control of documents of external origin:
		6.14.1		Identification of these documents is controlled by its sources of origin.
		6.14.2		It is the responsibility of the Quality Assurance Department to identify the documents of external origin. Once identified a list of these documents shall be prepared by categorizing them on the basis of source or type of document as per the prescribed format. The list shall be updated annually. The distribution of these documents shall be controlled under the strict supervision of QA Head. (8. List of Documents of External Origin)
				Note: Master copy of all the documents shall be maintained by QA or any other person designated by Management in the documentation cell. The documents in force shall be maintained separately from that not in force (obsolete).
		7		Reporting:
				Annexure 1 to 8
		8		Annexure
				Sr.No		Title								Pages
				1		Document Training Questionnaire Format								1
				2		Document Training Record								1
				3		Intimation for Document Review								1
				4		Request for Document Change								1
				5		Master List of Documents								1
				6		Request for Document								1
				7		Distribution of Document								1
				8		List of Documents of External Origin								1
		9		References:
				10.1	QA/001, Rev 00: Standard Operating Procedure for writing Standard Operating Procedures.
		10		Distribution:
				Master Copy								Archived in Quality Department
				Controlled Copy 1								Quality Department
				Subsequent Controlled Copy								Department making request
11			History:
			Revision Number						Change Summary
			00						None

Company Logo	Company Name
Document Training Questioner
Reference SOP No.		QA/002	Page No.	1 of 1

Training Module		Date of training	Date of Evaluation	Training imparted by	Document No
Title

                                                                                                                       

S. No.	Questions	Answers	Marks
1
2
3
4
5

Trainee	Name	Department	Signature	Date

                                                           

Total Marks			Evaluated by	Q.A. Approval
Marks Scored		Signature
Evaluation status		Date
Remarks, if any

Company Logo	Company Name
Document Training Record
Reference SOP No.		QA/002	Page No.	1 of 1

Document Number:			Document Revision:
Document Title:
S.No	Name of the Person trained	Signature		Date	Training imparted by
1.					Signature	Date
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Company Logo	Company Name
Intimation for Document Review
Reference SOP No.		QA/002	Page No.	1 of 1

S.No.	Document Category		Document Number	Effective Date		Revision No.	Department
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Remarks:
		Issued By:			Authorized By:
Name:
Designation/Role:
Signature:
Date:

Company Logo	Company Name
Request for Document Change
Reference SOP No.		QA/002	Page No.	1 of 1

Department Making Request:
Title of Document:				Document No.:
Change in		Proposed Change (Attach sheet if space not sufficient)
Purpose and Justification:
Retraining Required:
Effect on Established QMS and Process Validation:
	Requested By:		Departmental Approval:
Name:
Designation/Role:
Signature:
Date:
Comments:
Received in Quality Department By: Comments:
Training Required:
Effect on Established QMS and Process Validation:
Change Authorized By: Name: Designation: Signature and Date:

Company Logo	Company Name
Master List of Documents
Reference SOP No.		QA/002	Page No.	1 of 1

Document Category:
S.No	Document Number		Title		Effective Date
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		Prepared By:		Authorized By:
Name:
Designation/Role:
Signature:
Date:

Company Logo	Company Name
Request for Documents
Reference SOP No.		QA/002	Page No.	1 of 1

Department Making Request:
Title of Document:						Document No.:
Number of Copies:
Purpose and Justification:
	Requested By:			Departmental Approval:
Name:
Designation/Role:
Signature:
Date:
Issuing Department:
Comments:
Type of Copy issued: (Tick whichever is applicable)		Controlled Copy			Uncontrolled Copy
Copy Number:
Number of Copies issued:
	Issued By:			Authorized By (MR):
Name:
Designation/Role:
Signature:
Date:

Company Logo	Company Name
Distribution of Documents
Reference SOP No.		QA/002	Page No.	1 of 1

SOP Number:

SOP Title:

Master Copy

Archive at:

Date:

Signature:

Record for Controlled Copy

Sr.No

Controlled Copy No.

Date of Issue

Issued By Signature

Issued to Department

Issued to Signature

Date of Retrieval

Retrieved By

Date of Destruction

Destroyed By

1

2

3

4

5

6

7

8

9

10

Record of Uncontrolled Copy

Sr.No

Date of Issue

Issued By Signature

Issued to Department

Issued to Signature

Sr.No

Date of Issue

Issued By Signature

Issued to Department

Issued to Signature

1

4

2

5

3

6

Company Logo	Company Name
List of Documents of External Origin
Reference SOP No.		QA/002	Page No.	1 of 1

Document Category:
S.No	Document No.*	Document Name		Volume	Revision/ Edition	Archived At
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		Prepared By:	Authorized By (MR):
Name:
Designation/Role:
Signature:
Date: