ORAL DOSAGE FORM SOPs

1.0 PURPOSE

To provide entry and exit procedure into the factory.

2.0 SCOPE: 

This SOP is applicable to all the personnel enter into the factory.

5.0 PROCEDURE:

The process for entry and exit of the personnel into the factory is stated as below:

5.1       EMPLOYEES ENTRY:

5.1.1     Enter through main gate.

5.1.2     In case of own vehicle, Park the vehicle in parking area and follow the safety regulations.

5.1.3     Enter the security frisking area.

5.1.4     Handover all non-allowable items like, but not limited to, electric / electronics goods, chewing / Smoking, tobacco, medicines. Note: Mobile phones are allowed only for identified personnel.

5.1.5     If the biometric attendance recorder is not working, enter the time in and out in the register at Security Office manually.

5.1.6    Enter into the respective workplace, as per entry /exit procedures of respective department.

5.2       EMPLOYEES EXIT:

5.2.1    In case of leaving the factory within working hours, get the approved gate pass from department head as applicable.

5.2.2    Upon completion of shift / intermit departure from workplace, handover the responsibilities to next shift personnel and exit from respective department.

5.2.3    Collect the deposited belongings if any from security Walkout through the personnel movement area.

5.3       CONTRACT PERSONNEL (CP) ENTRY:

5.3.1    Enter through main gate.

5.3.2    Enter the frisking area.

5.3.3    Handover all non-allowable items like, but not limited to, electric / electronics goods, chewing / smoking, tobacco, medicines. Note: Mobile phones are allowed only for identified personnel.

5.3.4    Enter the time in and out in the register with signature at Security Office manually

5.3.5    Enter into the respective workplace, as per entry /exit procedures of respective department.

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1.0 PURPOSE

To provide a procedure for preparation of Organogram.

2.0 SCOPE: 

This SOP applicable for the preparation of the preparation of Organogram          

5.0 PROCEDURE:

5.1       The dept.-Head/ Section in-charge shall assign the sequence of Organogram on the basis of designation and reporting system.

5.2       The plant Organogram/Schematic shall be designed as per attached Annexure-01.

5.3       The department Organogram/Schematic shall be designed as per attached Annexure-02 (for different department designation may differ).

5.4       The boxes/columns specify the name/designation of person to his immediate senior person.

5.5       The Black arrow represents: Reporting to and direction.

5.6       The top management represents the Director of Management controlling the activities.

5.7       The middle management represents the Plant head/Corporate Level Managers.

5.8       The site managements represent below the department head.

5.9       The size of column shall vary accordingly.

5.10     The column of senior employee shall be upward than junior employee represents the designation.

5.11     The distance between column shall vary depends upon the number of reporting employees/designation.

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1.0 PURPOSE

To lay down a procedure for conducting induction training for any new recruits (s)

2.0 SCOPE: 

This procedure shall be applicable to all new recruit(s) appointed on the permanent roles of the organization.          

5.0 PROCEDURE:

5.1       Any new recruits shall be inducted as per the following procedure

5.1.1    HR Head / his / her designee shall explain the following to the new recruits

5.1.1.1  A general overview of the organization and culture through the induction Presentation

5.1.1.2  Brief overview of the company and organization structure.

5.1.1.3  Work related policies, procedures and safety

5.1.1.4 Inputs on cross- functional team and functioning of related departments.

5.1.1.5 The new recruit(s) shall be given orientation on the following:

• Vision, Mission and Organizational values
• Quality policy
• Zoning policy
• Factory / Office timings
• Reporting illness
• Lockers / Uniforms / Parking / Canteen
• Company objectives
• PF and all applicable statutory form fill ups

5.2  The HR Head or designee shall conduct a brief tour of the location and introduce the new recruits(s) to the functional leads.

5.3  A personal file and training file for new recruits (s) shall be opened.

5.4  Specimen signature log shall be signed by the new recruits(s) as per Annexure-2 within one week of joining.

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PURPOSE

The purpose of this Procedure is to provide a guideline for hire or Contract Security Personnel to protect its Employees, Facilities, Assets, and Operations.

SCOPE: 

This Procedure is applicable to the factory security to protect its Employees, Facilities, Assets, and Operations.

5.0 PROCEDURE:

5.1       Hiring of Security:

5.1.1    Oversight: for employees' behaviour and quality.

5.1.2    Conduct: Behaviour through policies and procedures.

5.1.3    Weapons: Allow use of Firearms or Weapons by any of its Deployed Guards.

5.1.4    Equipping: Usage of Identification, communications device, and any other necessary equipment for the job

5.1.5    Contract:  Include performance standards and monitoring provisions

5.1.6    Incidents: Ensure ability to receive and assess incident reports and other complaints

5.1.7    Vetting:  Background to be checked and avoid hiring anyone with history of abuse. Reference checks antecedents and verification of prospective guards /supervisors to be conducted by the security agency. Selection made in consultation with location Head HR.

5.1.8     Training: The agency/service provider should have well trained personnel on Security and Fire Safety who conform to normal physical and medical standards. The agency should deploy ex-servicemen or personnel who have undergone training in firefighting, basic first aid and hand-to-hand combat / self-defence. The security agency will ensure that periodical training program given to the supervisors to keep them updated about the latest needs of the company and relevant documentation in regard to the trainings conducted to be maintained Plant Head HR

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1.0 PURPOSE

To provide procedure for Pre-employment and Annual Health Check-up for all Employees.

2.0 SCOPE: 

This SOP is applicable to all the staff of Manufacturing facility

5.0 PROCEDURE:

5.1       FOR NEW EMPLOYEE:

5.1.1    Upon acceptance of new employee and after successful technical and HR interviews of the candidate and before joining the organization, the candidate should undergo medical checkup.

5.1.2    Candidate shall be sent with medical examination introductory letter along with the offer letter, suggesting the name of hospital, date and time of medical examination.

5.1.3    For international candidates, they may undergo medical checkup at their convenient place with pre consent, however all the test remains as same.

5.1.4     Follow up with medical officer for medical fitness certificate of the candidate. Ensure all tests are conducted as per the agreement with the hospital.

5.1.5    Incase candidates under gone pre-employment medical check-up outside.; receive all medical reports and medical fitness certificate.

5.2       FOR EXISTING EMPLOYEES:

5.2.1     Make Schedule for annual medical checkup for employees who completed minimum six months of service in the company. Ensure all the tests are covered as per the agreement with the Hospital/ Diagnostic center.

5.2.2    Attend the annual medical examinations as per scheduled plans on informed date.

5.2.3     In case the employee unable to undergo medical checkup on scheduled dates, on resuming for duty, issue introductory letter to employee designated hospital or medical center and get examined.

5.2.4    Follow up for medical reports of all employees and share the reports with concerned employee and respective departmental head.

5.2.5   After the successful completion of test, review the comments of medical officer and medical examination reports.

5.2.6    As per the nature of work / EHS identifies Employees to undergo Specialized Medical Examination

5.2.7    Consult the doctor for treatment of any major / minor health problems.

5.2.8    Record the medical reports in respective medical file.

5.2.9    Coordinate with HODs to check the good health status of the employees of the company.

5.2.10  Encourage employees to report their health status whether they are suffering from cuts, wounds, cold, cough and rashes, etc. so that their work in direct exposure to product can be restricted.

5.2.11   Ensure such personnel are not working in direct product exposure area.

5.2.12   Ensure proper Hygienic practices are followed at all time in work place.

5.2.13   Report accidents / illnesses during work to HOD / HR.

5.2.14   It’s the moral responsibility of every employee to inform immediately to HR about any infectious disease.

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1.0 PURPOSE

To provide a guideline to maintain all Personnel Hygiene and health at workplace includes commitment of the Management, Roles and Responsibilities at different levels in the organisation.

SCOPE: 

Applicable to all Employees of the company including Visitors, Contractors, and Suppliers associated.

5.0 PROCEDURE:

5.1         PERSONNEL HYGIENE AND HEALTH

5.1.1    Personnel should practice good sanitation and health habits. That is to say have daily shower at least once before attending site, have proper haircut, regularly clipping ones nails.

5.1.2    Personnel should avoid direct contact with unprotected hands, raw materials, intermediates or finished, unpacked products.

5.1.3    Personnel should be instructed to wash and sanitize their hands before entering the production areas.

5.1.4    Personnel should be instructed to regularly wash hands mainly when coming out of toilets, before and after eating.

5.1.5    All employees undergo periodical medical checkup at least once in a year ± 3 month, apart from this yearly medical check-up those who come in direct contact with the product should be arranged specific medical examination on recommendation of appointed occupational doctor. 

5.1.6    These records should be maintained in the QA archive with respect to medical regulatory restrictions.

5.1.7    Personnel should not be permitted the wearing of make-up, false eyelashes or fingernails or jewelry that could tear gloves.

5.1.8    Personnel should not be permitted into clean areas without proper training of gowning practices and enforcement of above points.

5.1.9    Personnel suffering from an infectious disease or having open lesions on the exposed surface of the body should not engage/allowed to enter clean production areas.

5.1.10   All employees should be instructed to report about their illness or abnormal health condition to their immediate supervisor so that appropriate action can be taken.

5.1.11   Change rooms and washrooms should be separate for males and females with adequate facilities for personnel cleanliness such as washbasin with running water, clean towels or hand dryers, soap, disinfectants should be provided.

5.1.12   The change rooms should be provided with cabinets for the storage of the personnel belongings of the personnel.

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1.0 PURPOSE

To lay down a procedure for specification and laundering of Primary and Secondary Uniforms.

2.0 SCOPE: 

This Standard Operating Procedure is applicable to all primary and secondary uniforms of manufacturing, primary, secondary packing areas located inside the production block, Quality Assurance and Quality Control, Engineering & Housekeeping

5.0 PROCEDURE:

5.1         Tools

5.1.1    Washing Machine.  

5.1.2     Heavy irons 2 No.’s.

5.1.3    Linen trolleys.

5.2       Cleaning agents

Below mentioned cleaning agents shall be used for linen.

5.2.1.   Washing powder

5.2.2     Liquid Emulsifier

5.2.3     Neutralising agent

5.3       Precautions

5.3.1     Ensure that the uniforms are sorted area and color wise and washed separately.

5.3.2     Ensure that the pockets of uniforms are emptied, zips done up, strings etc., tied together to prevent them from tangling and pulling off.

5.3.3     Remove uniforms from washing machine and driers immediately after the cycle is completed to avoid creasing.

5.3.4     If any abnormal stains remove them before washing.

5.3.5     The suitable solvents used to remove ink, rust; furnace oil stains shall be stored in closed container and in well ventilated area.

5.3.6     Check the uniforms before ironing, if any mending work is required, hand it over to Housekeeping   supervisor for rectification

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1.0 PURPOSE

To provide a procedure for daily cleaning & sanitization.

2.0 SCOPE: 

This procedure is applicable to daily cleaning and sanitization of the Facility

5.0 PROCEDURE:

5.1  Clean all areas using bactericidal and cleanol alternate weekly and IPA- dry mop / wet mop as required.

5.2  Cleaning personnel shall be trained for the following cleaning procedure in the respective areas.

5.3  Manufacturing, Packing and Warehouse shall ensure availability of all cleaning aids in the premises.

5.4  All floors of storage areas (Semi-finished goods and packaging materials), change rooms, secondary packing areas passages shall be dry moped/wet mopped and further sanitized using 5% v/v solution bactericidal on alternate basis.

5.5  All controlled areas (Dispensing area including dispensing booth, Granulation areas , Compression areas, Coating areas, inspection room, primary packing room, airlock and corridor after air lock and all sections shall be sanitized daily and all other areas shall be sanitized on weekly twice basis. It is the responsibility of the QA Designee, Manufacturing &Packing and Warehouse to ensure correct cleaning agents are used. Dilution of cleaning agents shall be done as per SOP on Preparation of Disinfectant solution.

5.6  When there is no production all areas shall be cleaned twice in week.

5.7  Walls shall be cleaned once weekly using a dry lint free cloth and further sanitized with 70% v/v Isopropyl Alcohol solution.

5.8  All toilets shall be cleaned through acid based cleaner and wash room shall be cleaned and sanitized along with all the areas including the plant premises on daily basis and entries shall be made by respective area responsible person as mentioned above solution (refer point no 5.4).

5.9  Product handling areas cleaning shall be done by respective operator/department personnel and recorded in logbooks.

5.10 QA/QC shall verify the logbooks of all areas for correctness and compliance of the procedure.

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