SOP ON JOB DESCRIPTION

This Document describes (Standard Operating procedure) SOP for procedure for responsibilities of all functional department & individuals job description

SOP on JOB Description

OBJECTIVE :

To lay down the procedure for responsibilities of all functional department & individuals job description.

SCOPE :

This procedure is applicable for QA (Quality assurance), QC (Quality control), Production, Engineering, Warehouse and P&A department.

The responsibility of functional departments explained in this SOP shall be used as guidance for defining job description of individual persons working in the department.

RESPONSIBILITY :

• Officer / Executives of each functional department
• HODs of each functional department

PROCEDURE :

To maintain a satisfactory system of Quality Assurance and manufacturing of drug product, as per cGMP requirement. Total operation is divided into various functions, called as Departments.

• Quality Assurance
• Quality Control
• Production
• Warehouse
• Engineering
• Personnel & Administration

Each department shall be provided with defined responsibility to perform the task for manufacturing of drug product to meet cGMP requirement.

Responsibilities of Quality Unit :

The term Quality Unit is defined as the unit to ensure the operation associated with system are appropriately planned, approved, conducted and monitored. The quality unit includes quality assurance & quality control activity. The quality unit shall be responsible for below but not limited to,

• Ensure analysis, approval and rejection of active pharmaceutical ingredients, excipients, intermediates, finished drugs products, packaging components and products that are under stability studies.
• Ensure batch manufacturing and packing records are reviewed for compliance and analytical records for control of the critical process steps before release of the drug product for distribution.
• Ensure that all deviations are investigated properly and appropriate CAPA has been taken to resolve the root cause of the deviation.
• Ensure that all the specifications, test methods, study protocols, reports and master documents are reviewed appropriately before approval for final distribution of such documents.
• All the factors that impact the quality of the intermediate and finished drug products shall be approved by Quality Unit to maintain the quality and safety of the drug product.
• Management of the internal and external inspection system to ensure that established system are followed at all level and shall identify any scope of improvement in the existing system and identification and implementation of appropriate CAPA.
• Review, assess and approve all the changes that have direct or indirect impact on quality, safety, identity, strength, purity and efficacy of drug product.
• Ensure market complaints, adverse drug reaction, product recall shall be properly recorded investigated, communicated by the Quality unit and Quality unit shall also be responsible for resolution of complaint and appropriate CAPA has been taken to avoid the reoccurrence.
• Ensure that stability studies are performed as per the customer/ regulatory requirement and sufficient data is available to support the shelf life of the drug product.
• Perform process performance of the product manufactured in a specific year, in term of annual product review.
• Ensure the internal or external calibration and validation program for analytical, measuring, manufacturing and engineering equipment to ensure the proper functioning.
• Ensure implementation of the documents and data control system, retention policy and approval of the key documents, SOPs, standard testing procedure (STPs), specifications, schedulers / planners and all other manuals and apex documents.
• Participate in management review of process performance, product quality and of the quality management system and advocating continual improvement and update in compliance with applicable national and international regulations.
• Ensure that equipment is purchased as per the requirement and installed and qualified in a manner and certify that the equipment is suitable for their intended use.
• Ensure out of specification, out of trends results, product failure are recorded, communicated and properly investigated to the level to avoid the reoccurrence and shall also ensure the proper segregation handling and storage of market returned, expired and recalled products.
• Ensure management of the vendor approval system and shall also ensure that the artwork management system for the packing materials is in place.
• Identify the gap as per the latest updating and to ensure that the identified gaps or requirement are bridged with implemented systems.
• Provide a proactive approach to identifying scientifically evaluating and controlling potential risk to the quality. It facilitates the continual improvement of process performance and product quality throughout the product lifecycle.
• Ensure that all agreements to the outsourcing agency, customer, and suppliers are in place.
• Maintain utmost secrecy about official information with respect to systems, commercial terms and condition, vendors etc.

Responsibilities of Production Department :

Production department shall be responsible for below but not limited to,

• Preparing SOPs for production activities and assisting in setting up production as per cGMP guideline.
• Preparation and review of the instructions for the production of in-process or finished products according to written procedures.
• Producing drug products and, when appropriate, performing in-process checks according to pre approved instructions.
• Review of production batch records (BMR and BPR) and ensuring that these are completed and signed.
• Make sure all production deviations are reported and evaluated and that major deviations are investigated and the conclusions are recorded.
• Make sure that production facilities are cleaned & sanitized as per defined frequency.
• Make sure that the necessary calibrations are performed and records are up to date.
• Make sure that the premises and equipment are maintained and shall ensure the preventive maintenance as per schedule and requirement.
• Make sure that validation protocols and reports are reviewed and approved.
• Make sure that new and when appropriate, modified facilities and equipment are qualified. Evaluating proposed changes in product, process or equipment.
• Plan, organize co-ordinate and control production activities as per the requirement of monthly production plan.
• Make control day to day production activities and shall ensure that all the activities are performed as pre approved procedures and are in compliance with cGMP.
• Ensure optimum productivity with quality to look after usage and capacities and preventive maintenance of plant and machineries.
• Perform the investigation for market return, recalled and product failure. Production department shall ensure that all the production related deviations are recorded and investigated.
• Co-ordinate with production, stores, maintenance and Quality Assurance departments daily to function smoothly and to fulfill requirements as per the need and urgency.
• Review and verify the compliance to cGMP requirements and take responsibility of yields, final reconciliation of product and printed packing materials and scrap disposal from production area.
• Ensure all changes are controlled by change management system and complaints are investigated and CAPA has been initiated and implemented.
• Ensure the availability and intactness of tools, supporting accessories and other additional parts of the machines.
• Training and implementation of cGMP amongst the staff and workmen manufacturing and packaging activity.
• Preparation of budget and ensure spending within the budgeted targets.
• Maintain utmost secrecy about official information with respect to systems, commercial terms and condition, vendors etc.

Responsibility of Warehouse Department :

Warehouse department shall be responsible for below but not limited to,

• Preparing SOPs for warehouse activities and assisting in setting up warehouse as per cGMP guideline.
• Training and implementation of cGMP amongst the staff and workmen in Warehouse.
• Monitoring and timely accomplishing the calibration of weighing balances and standard weights by the government agencies and monitoring environmental control in Warehouse.
• Receiving of raw material and packing material according to the SOP on incoming material management.
• Monitoring and recording cleaning and sanitization in warehouse.
• Periodic stock verification of starting materials and stock reconciliation.
• Handling of retest/expired/ rejected starting materials & finished product in stores.
• Preparation of statements like stock statements etc as required by the management from time to time.
• Co-ordination with PPIC, purchase, engineering, production and QA to achieve monthly production plan targets by ensuring timely availability of all starting materials.
• Plan, organize co-ordinate and control starting materials inventory.
• Organize finished goods as per status (Release or under test) in finished goods store and dispatch in coordination with QA.
• Ensure all statutory records and documentation pertaining to stock ledgers and cGMP guidelines are completed on daily basis.
• Maintain utmost secrecy about official information with respect to systems, commercial terms and condition, vendors etc.
• Proper receipt, intimation segregation, storage and control of market returned and recalled goods.
• Investigation of warehouse related deviations and shall ensure that changes are controlled as per change management system.
• Provide required information and support for market complaint investigation and failure investigations.
• To carry out the self inspection as a member of self inspection team.
• Preparation of budget and ensure spending within the budgeted targets.

 Responsibilities of Engineering Department:

Engineering department shall be responsible for below but not limited to,

• Ensure validation and qualification of systems and review of departmental documentation.
• Planning and execution of plant and equipments preventive maintenance and breakdown maintenance.
• Implementation and training of engineering personnel in cGMP and safety policies.
• Review the plant system operation and productivity of machinery.
• Establish, lay down and implement SOPs as per cGMP, and safety requirements.
• Provide the necessary utilities like water, air and light and shall ensure that all the utilities are operated as per approved procedures and are in compliance with the specification.
• Investigation of all engineering related deviations and shall ensure that all changes and modification are performed through change management procedure.
• Support market complaint investigation, failure investigation and deviation investigation.
• Provide technical guidance pertaining to up gradation of existing machinery, equipment, system, etc.
• Provide technical guidance pertaining to purchase of new machinery, equipment, system, etc.
• Planning, mobilization and supervision of in-house projects related to plant and machinery and review the stock inventory control for engineering stores.
• Implementation and review of management policies and directives and co-ordination with external agencies and contractors and co-ordinations with all departments in the plant viz. warehouse, production, quality assurance, personnel and administration.
• Preparation of budget and ensure spending within the budgeted targets.
• Training and implementation of cGMP amongst the staff and workmen working in engineering department.
• Maintain utmost secrecy about official information with respect to systems, commercial terms and condition and vendors etc.

Responsibilities of P&A Department :

•  P&A department shall be responsible for below but not limited to,
• Design & implementation of policies related to recruitment, induction, training & development, performance management, employee services, and industrial relations etc.
• Preparation of budget and ensure spending within the budgeted targets.
• Continuously monitor the work environment to understand the needs and aspirations of the employees and plan necessary action.
• Oversee the statutory compliance related to the labour department, pollution, ESI/EPF.
• Effective management of shop floor employees to maintain productive industrial relations.
• Oversee and ensure trouble free services related to pest control, canteen, transportation, laundry, housekeeping and horticulture etc.
• Plan and execute the strategies related to high quality talent acquisition and development & retention there of development and implementation of an effective, fair and transparent performance management system.
• Take disciplinary action, circulars and leave management.
• Training and implementation of cGMP amongst the staff and workmen working in P&A and other departments.
• To ensure that all changes are performed as per change management system and shall ensure that all agreements with outsides agencies are in place.
• Maintain utmost secrecy about official information with respect to systems, commercial terms and condition, vendors and employee’s personnel information etc.

Preparation of Job Description (JDs) :

• While preparing the job description for individuals, it shall be ensured that JDs are in line with the departmental responsibility.
• Job description of all employees shall be prepared as per Annexure I. Job description shall include all responsibility which is carried out by individuals in day to day working. Job description shall be prepared after completion of the induction training of a new joinee and based on the JD training need identification shall be prepared.
• While preparing job responsibility it shall be ensured that there are no gaps or unexplained overlaps in the responsibilities of personnel concerned with the application of Good Manufacturing Practice.
• It shall be also ensured that responsibilities of any individual are not so extensive as to present any risk to quality.
• The responsibility of personnel may be delegated to designated deputies having satisfactory qualification & experience to perform the job.
• After preparation of job description, employee should understand about his/her role and responsibility in the organization. Employee & Department Head shall sign the job description and forward the same to P&A.
• In case of new employee joining the company, the issue date of his Job responsibility shall be the date of joining in the department & effective date shall be after completion of training as per training need identification.
• In case of job responsibility changed in between the service period due to any reason the effective date is next date of the issue date.
• During absenteeism of employee, his/her senior or junior colleague shall perform his/her duties assigned in job description in consultation with their senior.
• Original copy of job description shall be maintained by the P&A department, photocopy of the same shall be kept by the incumbent & the department / section head.
• One copy of job description of key personnel shall be maintained by QA department for reference purpose.
• Review period shall be of three year from the effective date or if any change in assigned job responsibility in between review period whichever is earlier. JD shall be reviewed within ±30 days of the review period and the revised version of JD shall be issued.
• A list of personals JD shall be prepared as per Annexure II . This list shall be revised on yearly basis.

ANNEXURE : 

Sr. No.	Annexure No.	Title of the Annexure
1.	Annexure I	Job description
2.	Annexure II	JD’s index
3.	Annexure III	Organogram

 

ABBREVIATIONS

SOP	Standard Operating Procedure	QA	Quality Assurance
F	Format	No.	Number
CAPA	Corrective & Preventive Action	cGMP	Current Good Manufacturing Practices
BMR	Batch manufacturing Record	BPR	Batch Packing Record
PPIC	Production Planning & Inventory Control	—-	—-

 Annexure I 

Job Description

Department		Issue Date			Revision No.
Job Title		Effective Date			Experience
Incumbent		Employee No.			Qualification
Reporting to		Deputy of Incumbent			Date of Joining
Review Before
Responsibilities: · · · · · · · ·
Deputy of Incumbent   Name:          Designation:
In the absence of Mr./Ms.   (Name)    Mr./Ms.   (Name) will be responsible for all activities mentioned above.
Mr./Ms. (Name)  :  _________________                                 Date: (Sign)
Please inform the immediate superior if deviations from the description have occurred in everyday practice
Accepted by Incumbent:   _________________ (Sign) Name          :   Dated          :  _________________			Approved by Superior         :     __________________ (Sign)   Name             :   Designation   :   __________________   Dated             :   __________________
cc : €  Copy for incumbent €  Copy for superior €  Copy for Quality Assurance record

 

 

Annexure II 

JD INDEX

Department		Section
Effective Date		Revision No.

 

Sr. No.	Name	Designation	Effective Date	Review Before

 

Prepared By	Reviewed By	Approved By
Sign/Date	Sign/Date	Sign/Date

Annexure III

  ORGANOGRAM

 

Prepared By	Reviewed By	Approved By
Sign/Date	Sign/Date	Sign/Date