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Standard Operating Procedure (SOP) of Workplace instructions pertaining to health protocol during COVID-19 (Corona Virus) pandemic to be complied with by the pharmaceutical drug manufacturing plant.

Health Protocol at the Workplace (Pharma) during COVID-19 (Corona Virus)

1.0   PURPOSE

• • The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for health safety practices/protocols at the workplace and manpower movement during COVID-19 (Corona Virus) Pandemic.

2.0   SCOPE

• • This SOP shall be used as such for Healthcare practices and protocol at the workplace and manpower movement during the COVID-19 pandemic.

3.0   RESPONSIBILITY – DURING COVID – 19 (CORONA VIRUS)

• • All the employees, workers, and visitors shall be responsible to follow the instructions as per SOP.

• • The Technical Staff of the QA department shall be responsible for the preparation of the SOP.

• • All the Department heads shall be responsible to follow the instructions as per SOP.

• • Ensuring training and effective implementation of SOPs.

• • Head QA shall be responsible for ensuring compliance of SOP to regulatory requirements.

• • Review of draft SOPs and approval of final SOPs.

4.0   PROCEDURE – DURING COVID -19 (CORONA VIRUS)

• • General Instructions during COVID – 19 (Corona Virus) Situation:

• • The company will abide by all the rules and regulations/guidelines issued by the Government of India and Local Administration in wake of COVID-19 (Corona Virus) situation, including the conditions on which the induction was allowed by the local Administration in the pharma plant.

• • All employees must maintain a social distancing protocol and strictly follow the shift movement timings.

• • The company will not induct employees against the movement and the stay plan will never violate the condition of interstate/ inter-district movement of employees.

• • Permit the transportation only during shift timing in-vehicle having pass issued by the local administration.

• • Boarding of Employee at Authorized Vehicle :

• • Before boarding the authorized vehicle, the hands of all employees shall be sanitized.

• • All employees shall go under thermal scanning.

• • Monitor the body temperature of each and every person using non-contact Infrared thermometer.

• • The normal range of temperature is 36 to 37.6 deg- C or 96.6 to 99.7 Degree Fahrenheit.

• • Do not allow the person’s having higher temperatures than this to board the vehicle and the nearest hospital shall approach for further investigation.

• • All (including the driver of the vehicle) shall wear masks and all shall sit at a distance at least 1 meter from each other during the travel.

• • Provide the instructions to all the employees to avoid touching any other surface during transport e.g. railings, windows, seats, etc.

• • Entering of Employee at Company Premises :

• • Park the vehicle at the entry gate of the plant.

• • While de-boarding. Sanitize the hands of all personnel again before entry into the industrial unit.

• • Stagger the entry of every individual person to maintain social distancing.

• • Record manual attendance and maintain these records on a daily basis for each and every person present in the plant.

• • Employees shall not be asked to sign on an individual basis neither they shall use the biometric attendance system.

• • A dedicated person(s) shall enter the attendance either in the computer system or in the register as per the convenience of the company/unit.

• • Electronic punch card system if available may be utilized but in that case, it shall be ensured that there is no kind of physical contact of body parts of a person to any surface other than to the individual punch cards in his/her possession.

• • Discontinue the frisking of employees temporarily.

• • Entering of Employee at the workplace during COVID-19 (Corona Virus) Situation :

• • Provide a hand wash provision to wash hands with soap and water at the entry and every person wash his hands before entry to the work area.

• • Temperature monitoring on a daily basis at least twice in a day (morning and evening ) with a non-Contact Infrared thermometer and a dedicated person shall record.

• • In case any person is observed with abnormal temperature. Brought into the notice of the nearest recognized hospital through HR department immediately 

• • Canteen Practices during COVID-19 (Corona Virus) Situation:

• • Measures to avoid employee mix-ups like having only two people sit per table instead of four.

• • Preferably use disposable cutlery and plates.

• • In case, steel utensils are used, these should be washed properly with hot water and detergent and well dried before use.

• • Serve the food by only canteen personnel wearing gloves and masks.

• • Make the provision for hand wash with soap at entry and exit doors of canteen premises.

• • Sanitize the canteen areas in the morning and evening on a daily basis and record.

• • Stagger all meal timings to avoid crowding and forfeiting provisions of social distancing.

• • Examine the canteen vendor periodically by an in-house or outsourced doctor appointed for the purpose.

• • Change room Practices during COVID-19 (Corona Virus) situation:

• • The limited number of employees shall enter the change room or washroom at a time.

• • Use washed and sanitized garments daily.

• • Clean and disinfect the areas that are frequently touched like phones, door handles, lockers, etc frequently on a daily basis.

• • Engineering Practices during COVID-19 (Corona Virus) situation:
    

• • Only dedicated personnel should access the service areas and should use their own tools which shall not be shared.

• • Sanitize all tools before and after use.

• • Restrict the entry of maintenance personnel into core manufacturing and QC areas.

• • Such entry shall only be done in case of breakdowns subject to the adoption of complete gowning procedures including wearing of face masks and gloves.

• • Follow the minimum manning on the shop floor and QC Lab.

• • Only essential manpower and small work teams shall work.

• • Stores Practices during COVID-19 (Corona Virus) situation:

• • Once the raw materials etc are received at the receipt bay. Sanitize the surface (preferably with 70% IPA  in addition to de-dusting.

• • Perform the de-dusting without use of a pneumatic blower.

• • Surface sanitize the materials & sampling tools both.

• • Keep the materials sanitized for at least 5 minutes before use.

• • Dedicated personnel within respective work-teams shall handle the materials.

• • Sanitize the cargos carrying finished goods outside the containment zone or bringing raw materials etc to the units inside the containment zones during every visit before loading, of finished goods and/ or unloading of raw materials, etc.

• • Ensure that the driver and conductor accompanying cargo vehicle scanned thermally and sanitized during every such visit(s).

• • Review all cleaning sanitization procedures for across sites regularly; e.g. for potentially increasing frequency of cleaning of equipment surfaces.

• • Manufacturing Practices during COVID-19 (Corona Virus) situation :
    

• • Increase the frequency of cleaning and sanitization for common areas. Especially for areas with the highest risk of transmission(i.e. areas with maximum personnel movement), such as corridors, changing rooms, cafeteria, washrooms.

• • All materials used in production processes should either be sterilized or surface disinfected while transferring in from outside areas

• • Put dedicated cleaning & sanitization procedures in place for all objects coming in frequent contact of personnel, such as phones, door handles, PLC screens, railings, chairs, table-tops, taps, bins, door touchpads, cross-over benches, etc.

• • Provide the additional facilities/equipment (such as hand wash, alcohol-based sanitizers, gloves) to carry out preventive activities in common and critical areas.

• • Explicitly train all personnel to strictly follow defined norms, such as Gowning controls, including usage of face masks and goggles where risk is elevated (e.g. for aseptic manufacturing)

• • Behavioral hygiene rules: hand washing, hand sanitization

• • ‘Deep cleaning’ procedures should be established for critical areas in-case any contamination/infection is suspected or observed With increasing numbers of infected or first-degree affected persons, additional mitigation.

• • Perform the microbiological monitoring of the manufacturing area regularly and any change in flora if gets notices shall report immediately.

• • If any employee/ contract workmen/ visitor is identified for potential infection symptom(s), such person(s) shall ask to sit at the designated place till further instructions.

• • Plant Head will take the call along with the local medical team, HR Head to inform his/her family and facilitate the person(s) transfer to his/her home or hospital as per the advice of medical experts.

• • Once the person is moved in a dedicated Ambulance or vehicle.

• • Ensure that the area sanitize thoroughly & no one will allow to use it till further clearance post medical reports of the person kept in that room

• • Use appropriate personal protection equipment (PPE’s) while handling such case(s).

• • Use the speakerphones of intercom and other phones instead of holding phone receivers near to face.

• • Management shall ensure that displays (Computer print outs) pertaining to social distancing, sanitizing, hand wash instructions are displayed at all appropriate and prominent places in the company/unit.

• • Personal And Administration (HR) during COVID-19 (Corona Virus) situation :

• • Strictly Prohibited: Possession or consumption of any kind of tobacco product and/or chewing gums.

• • Plant Management shall ensure that these products are not in possession of any person present on their premises.

• • There is every probability of person(s) who may try to leave the premise to the places of their homestay after duty hours.

• • The entire responsibility of the management to ensure that this does not happen.

• • The management shall depute a responsible person who shall monitor the prescribed conditions for ensuring proper hygiene, social distancing, and

• • All other such practices under the guidelines of health protocol are strictly adhered to by the staff in letter and spirit.

• • The responsible person shall record such compliances on a daily basis.

• • Company management shall authorize some person to monitor requisite compliances through CCTVs installed in the premises and violations observed if any. Self dealt through appropriate measures.

• • Any kind of renovation/construction activities in the premise shall remain prohibited.

• • Use of conference and training rooms: These shall prohibit during this period.

• • Conduct meetings by teleconference.

5.0   ABBREVIATIONS AND DEFINITIONS – COVID-19 (CORONA VIRUS) :

• • SOP:         Standard Operating Procedure

• • QA:         Quality Assurance

• • COVID-19 (Corona Virus):

• • COVID-19 is an infectious disease caused by the most recently discovered Corona Virus.

• • This new virus and disease were unknown before the outbreak began in Wuhan, China, in December 2019.

• • COVID-19 is now a pandemic affecting many countries globally.

• • Pandemic:

• • A pandemic refers to an illness that has spread over several countries or continents, usually affecting a large number of people.

• • It takes into account where it is located and how it is spreading.

• • Potential infection symptom of COVID-19 (Corona Virus):

• • The most common symptoms of COVID-19 are fever, dry cough, and tiredness.

• • Some patients may have aches and pains, nasal congestion, sore throat, or diarrhea.

• • These symptoms are usually mild and begin gradually.

• • Some people become infected but only have very mild symptoms.