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EHS-085 General Security Procedure for GMP Manufacturing Area

DepartmentEnvironmental, Health and SafetyDocument noEHS-085
TitleGeneral Security Procedure for Manufacturing Area
Prepared by: Date: Supersedes: 
Checked by: Date: Date Issued: 
Approved by: Date: Review Date: 

1. AFFECTED PARTIES

All Environment, Health and Safety personnel

2. PURPOSE

To detail the General Security Requirements and Procedures for persons entering the site to access the Buildings.

3. SCOPE

Site Security Team ensures a high level of awareness for security measures implemented for general site access and for the manufacturing building amongst all staff is of critical importance not only for our customers and our integrity as a supplier of prescription medicines but also for continued compliance with the conditions of our licenses to manufacture, import and export Pharmaceutical products.

Site Security Team ensures the followings:

– Local government and site policy requirements for the handling of controlled substances;

– Compliance with site security, Corporate EH&S and Corporate Quality Guidelines;

– Control of access to areas where contamination may result from unauthorised or untrained entry;

– Control of access to areas containing Hazardous Chemicals;

– Control and access to areas where printed packaging materials, raw materials, finished product and propriety information is either stored or can be accessed;

Effective security for the GMP site relies on:

– Conditional entry and management of all vehicles and personal entering site;

– Effective use of the installed ‘Access Control’ system;

– Effective monitoring of the installed ‘CCTV’ and ‘Alarm’ systems.

4. RESPONSIBILITY \ BUSINESS RULES

4.1 Business Rules

The following business rules apply for access to the GMP Manufacturing Building:

4.1.1 Entry into the Manufacturing building is ‘Restricted’ to site employees and/or Approved (read inducted) contractors.

4.1.2 Visitors and un-approved contractors are ‘Not’ permitted entry into the site building unless accompanied by a permanent staff member.

4.1.3 It is the responsibility of the hosting site staff member to remain with the visitors or contractors for the duration of their visit, whilst inside the GMP building.

4.1.4 Visitors and un-approved contractors are not permitted to remain inside the site building during meal breaks unless supervision can be provided until staff return.

4.1.5 Staff members and contractors working in the site building must display a Photo ID badge or Visitors badge at all times, whilst in the building.

4.1.6 Only approved staff members are permitted in areas where raw materials, printed materials and finished product is stored.

4.1.7 After hours entry to the building is by pre-programmed access on personal ID badges ONLY.

4.1.8 Security Guards are NOT permitted to provide entry into the Manufacturing building for persons who do not have approved access on their personal ID cards.

4.1.9 Security guards are also empowered to deny access to any person, who cannot provide photo identification on entering site, an authorized (read programmed) ‘ID’ badge to enter a building or who is not accompanied by a person approved for access.

4.1.10 Alarms activated by the building Security and/or Plant Systems are to be investigated and details recorded in the Security Site Log.

4.1.11 All ‘off-site’ monitoring centre calls and responses are to be logged into the Site

Security Site Log.

4.1.12 All after-hours entry into the site must be recorded in the Security Site Log or run sheet.

4.2 Overall Responsibilities      

4.2.1 Overall Security responsibility for the site rests with the Financial Director, to whom the Security Management Team reports.

4.2.2 Operational Security responsibility for the GMP buildings rests with the Facilities Manager reporting to the HR/EHS Manager.

4.2.3 Compliance with Security Policy and Procedures in general is the responsibility of all Departmental Managers and Team Leaders.

4.2.4 Physical Security, Security Response and bi-hourly security and fire watch patrols of the buildings are the responsibility of the On-site Security team.

4.3 Security Management Team Responsibilities

4.3.1 To oversee all security operations at the GMP site.

4.3.2 Ensure the general safety of colleagues and assets on site as well as the general safety of visitors and contractors whilst on site.

4.3.3 To ensure that wherever possible security policy and operations comply with the Corporate Security Minimum Requirements.

4.3.4 To ensure effective reporting of security events to local and corporate management.

4.3.5 To maintain the security assets, equipment and procedures on site.

4.4 Facilities Manager Responsibilities

4.4.1 Local GMP site Security point of contact.

4.4.2 Daily management of security schedules, access and provide security information and assistance for travelling colleagues.

4.4.3 Maintain adequate documentation and records.

4.4.4 Maintain communication and cooperation with all security stakeholders.

4.4.5 Support security management team and on-site guard force.

4.4.6 Maintain security compliance to EH&S and Quality requirements for security.

4.4.7 Maintain the GMP buildings, lighting and security hardware / systems to provide adequate physical security in accordance with business requirements.

4.4.8 Conduct / promote ongoing security risk assessments.

4.4.9 Conduct / promote security awareness and training.

4.5 Site Security Team Responsibilities

4.5.1 Ensure regular security patrols to ensure both the physical and fire watch security of all company assets, the surrounding external grounds and fences are properly secured.

4.5.2 Report any assets not secured and temporarily secure until site staff can respond.

4.5.3 Provide security to colleagues and site sponsored visitors in the event of physical threat and assist on occasions for special requests / events.

4.5.4 To assist in controlling and registering contractor and visitor movements onto site and directing people movements to reception or other buildings as requested.

4.5.5 To assume control of the site in the event of an emergency, direct vehicular traffic and guide emergency vehicles where required and as requested by the security team.

4.5.6 Manage the approved issue of ID badges and visitor/contractor day passes and badges.

4.5.7 To ensure that all external doors, gates etc are locked and secured at the appropriate times except when in immediate use by authorised personnel.

4.5.8 To prevent unaccompanied entry into all GMP buildings and in particular the after-hours.

4.5.9 To respond to and log Manufacturing Building alarms initiated by the Manufacturing Building Security and Fire alarm systems.

4.5.10 To ensure that Fire and Security Surveillance patrols are carried out every two hours in accordance with the requirements of our insurance schedule.

5. PROCEDURE

5.1 Building Access

Access to the GMP building is controlled by a global electronic access control system of pre-programmed personal ID badges and monitored by ‘On site’ security guard force. Personal ID badges provide controlled access to the various areas of the GMP building.

International colleagues can pre-register impending site visits via their local hosts for office access to the GMP building.

Visitor day passes permit site entry for visitors/contractors but do not provide entry into the GMP building.

Similarly any after-hours access to the GMP Building is by pre-programmed access card only.  Emergency entry to the building will only be granted after:

– A Security Guard has first verified your identity and received approval via telephone to permit access

– A Security Guard accompanies the person into and out of the building for the emergency or to retrieve any personal belongings

Security officers have the authority to refuse entry to the site to any person they cannot identify or to whom they do not have approval to allow on site or into the building for the unscheduled visit. Where staffs are required to work overtime, which involves after hours access into the Manufacturing plant, prior notification must be given to the Building Services Team to advise the security supervisor and enable access cards to be appropriately pre-programmed.

N.B: For both evening shift and after hours operations the Receiving / Dispatch dock-way roller doors should always remain closed except when in immediate use; i.e should be closed at the end of each day shift.

5.2 Normal Operating Hours for the Manufacturing Building

Manufacturing work two 9.5 hour shifts from Monday to Thursday, with a half hour changeover and a single 9 hour day shift on Fridays. Thus normal working hours for the Manufacturing building are:

Monday to Thursday From 6.30am to 2.00am the following morning Friday From 6.30am to 4.30pm

Manufacturing Contract Cleaning Staff occupy the building:

Monday to Friday From 6.00am to 11.00pm

Notes: Hours worked on Friday evenings and / or weekends are worked as overtime.

Laboratory staff may require access for brief periods on weekends to monitor the progress of long running analysis work being undertaken in the laboratory.

5.3 Evening Shift

A small production team generally works ‘Evening’ shift Monday to Thursday under the supervision of three rotating production Team Leaders, who are responsible for all people in the manufacturing building after 6.00PM.

Site security policy is that any person remaining in the building after 6.00PM must report their presence in the building to the Evening Shift Team Leader or equivalent. The Team Leader will then include the person’s name on the evening shift evacuation sheet.

Note: Contracted casual production workers are sometimes used.  Team Leaders will pick up evening shift casuals from the security gatehouse on arrival and accompany them to the production area.

5.4 Overtime

Manufacturing production staff may work overtime on the following shifts:

Friday From 4.30pm to 12.00pm; Saturday From 6.00am to 3.00am

For any such overtime access cards will be pre-programmed to permit access into the GMP building.

5.5 External Gates and General Access

The external gates are located each side of the western end of the Warehouse should be locked at accept when in immediate use.  Security Officers on patrol should ensure the gates are closed when patrolling the grounds.

Warehouse and Dock-Way Notes:

– Access to the warehouse / dock-way is generally limited to production staff, the management team and security.

– Access to the Receiving / Dispatch and Warehouse areas is restricted to the people wearing appropriate safety vests / clothing as per local government requirements.

5.6 Vehicle Control

All vehicles entering the site must STOP at the boom gate located at the main entrance to the site. After positive identification vehicle occupants with ID badges will be permitted entry into the site. Vehicle occupants without ID badges are required to show a photo ID and obtain a visitor’s day pass from the gatehouse before proceeding onto site.

Details of vehicles entering the site after hours should always be recorded in the site security log or vehicle register.

The Security Guard Force has the authority to refuse entry too or inspect any vehicle on exit from the site. Drivers, vehicle occupants must comply with security officer directions.

Parking beside or adjacent to the perimeter of the Manufacturing building, in front of the Laboratory / mail room or in front of any building exit is not permitted. The only exception will be when direct access to a work area is required for the purpose of unloading equipment and/or materials for building works, etc.

5.7 General ID Badge Policy for All Staff

It is site policy to provide a photo identification badge for all employees, approved sponsored contractors or international colleagues for access and ease of identification.

5.7.1 Identification badges must be worn at all times while inside the confines of the GMP site.

5.7.2 Requests for ID badges may be made by the department managers using the request form. Requests should be forwarded to the Security Management team for authorisation.

5.7.3 Identification badges must be presented to security personnel when entering the site whether individually or in a group such as a car club.

5.7.4 Failure to display an ID badge will require the individual if unknown to security to produce alternative photo identification to the security personnel and sign into the site visitor’s book.

5.7.5 Photo identification is required by all visitors / contractors entering site

5.7.6 People working inside GMP production areas may secure their identification badges in pockets or underneath uniforms for EH&S and GMP reasons; i.e. to prevent contact with product and or machines.

5.7.7 Lost badges must be reported immediately to the Security Management team, to enable the badge to be cancelled and a new badge issued.

Note: ID badges are approved and issued for personal access ONLY.  Thus personal ID badges are not to be lent to other individuals.

5.8 Terminated Employees

Managers must ensure that the ID badge and any facility keys held by the terminated employee are collected and returned to the Security Management team before the employee leaves the site.  (This includes locker, desk, cabinet keys, etc.)

5.9 Contractors and Visitors 

All visitors and contractors must produce photo identification and be signed into the site visitor’s book at the security gatehouse. Visitors and contractors will be issued a visitors badge and must display the badge at all times, whilst on the site. Security will ask visitors / contractors to wait at either the Administration or Manufacturing foyers for collection by the nominated site contact person before continuing on inside the site.

5.10 Building Alarms and Security Lighting

The Manufacturing Building is protected by alarm systems. Defective external building lighting and essential walkway / corridor lighting should be reported immediately and not be isolated for any reason without prior consultation with the to the Facilities Manager.

5.11 Travel Advisory Information

Site colleagues planning overseas travel can request travel advisory information from the Site Security Management Team prior to completing arrangements.The Site Security Management Team has access to Corporate Security Travel advisory information service and can also arrange emergency contacts etc for colleagues planning travel to countries of high personal risk.

5.12 Fire and Security Surveillance Schedules

At all times and especially when the building is un-occupied or during the evenings Security Officers, on duty are required to visually inspect / check defined patrol areas. The areas are defined by the patrol electronic button system to enable reporting of patrols to the security management team. The inspection / patrol should check for:

– Ensure that there are no signs of fire present in the building;

– Ensure that all entry, exit and emergency exit doors are secure;

– Check for signs of forced entry or fraudulent activity.

If a Fire is Detected, the Security Guards are to initiate emergency procedures immediately.

5.13 Additional Duties

At the completion of evening shift, if available, a guard may be present in front of the GMP building to monitor that no bulk materials (drums, buckets, boxes) or equipment is being removed from the building; i.e. The officer’s presence can also serve to ensure the safety of staff returning to their vehicles in the early hours of the morning.

6. DEFINITIONS / ACRONYMS

N/A

7. SUMMARY OF CHANGES

Version #Revision History
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