- Objective :To lay down a procedure for Entry and Exit for Executives, Staff, Visitors in Production Area (gowning and degowning procedure).
- Scope :This standard operating procedure is applicable for the entry and exit in Production Block of Pharmaceutical company.
- Executive / Staff / Visitors entering in production area shall be responsible to follow the Entry and Exit procedure as per this SOP.
- Head-Production / designee shall be responsible for compliance of this SOP.
- Accountability:Head-Production and QA shall be accountable for compliance of this SOP.
- Abbreviations and Definitions:
- Secondary Area (Core area): Area that comes in contact with product directly for example Fabrication Room, Compression Room, Capsule Room, Coating Room,Blister Packing Room.
- Primary Area : Area that does not come in contact with product directly (outer corridor and Packing Hall)
- Enter in the change room. Remove your footwear and keep in the shoe rack.
- Sit on the ‘Swing over bench’, lift both feet together and cross over to the other side.
- The ornaments shall not be carried inside the production area and shall be kept in the locker provided.
- Clean the hands with liquid disinfectant solution provided in the change room before entering in to production area.
- Visitors have to take primary gowning from the almirah and wear primary gowning (i.e. shirt, trouser, cap and footwear / shoe cover) as displayed in the photograph hanging in the change room. Check the tidiness of the primary gowning in the mirror.
- Executive and staff has to unlock the Locker, Wear your primary gowning (i.e. shirt, trouser, cap and footwear) kept in locker provided as displayed in the photograph hanging in the change room. Check the tidiness of the primary gowning in the mirrors.
- Enter in the Outer corridor through the other door of the change room. Person with this primary gowning can access to all the areas except the core area.
- For entry in the core area / secondary area, person shall enter in the secondary gowning room of respective Block. Secondary gowning rooms for entering Fab.-I, Fab.-II and Fab.-III, Liquid Oral Block and Gel / Ointment Block are provided separately. In secondary gowning cross the swing over bench, clean the hands with Handy Clean Spray System containing 70% IPA in the secondary change room and wear secondary gowning of specified colour as per respective area including snood and booty over the primary gowning before entering to the core area. Housekeeping personals shall wear secondary gowning (i.e. protective gown, mask and shoe cover) over primary gowning. maintenance technician shall wear secondary gowning (i.e. secondary gowning, mask and shoe cover) over primary gowning. Colour coding for Secondary Gowns
- White Colour Secondary Gown – For Production Block Tablets, Capsule and Gel / Ointment Block.
- Cream Colour Secondary Gown – For Production Block containing Liquid Product.
- For exit from core area, remove secondary gowning (i.e. mask/snood, booty/shoe cover, hands gloves and secondary gown) in secondary gowning room and cross the swing over bench toward exit door.
- Visitors, for exit from production area shall come back to the change room, remove primary gowning (i.e. shirt, trouser, cap, footwear) keep in almirah over the hangers. Visitors shall wear fresh dress on every entry into the production areas.
- Individual shall remove his secondary gowning for cleaning with every product change over and at the end of every shift.
- Individual remove /drop his primary gowning for cleaning at the end of every shift.
- For ease in sequential steps for gowning and degowning in the areas one can understand through the demonstrated photographs and can check the gowning in the mirrors.
- Master copy – Documentation Cell (Quality Assurance).
- Controlled copies – Documentation Cell , QA , Production, Quality Control, HR.
Reason for Revision
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube