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Wednesday, May 12, 2010

Standard Operating Procedure Title: Procedure for Hold

1.0 Purpose
1.1 It is established to assure quality in all aspects, and to avoid any unintentional contravention of Drug Act, cGMP and company standards.
2.0 Scope
2.1 It is applicable to all types of incoming and out going materials and all type of activities / process, conditions, equipment, documents, material and any “thing” (i.e. conditions, process, activity, material, equipment and document) which can affect quality directly or indirectly.
3.0 Responsibilities
3.1 Manager Quality Assurances.
3.2 Assistant Manager Quality Assurance.
3.3 Quality Assurance Officer.
4.0 Procedure
4.1. During the routine in process checks if any thing found to be in contravention of any requirements, regulations, system (which are well defined in SOPs, SMPs, and Product Specification) matter will be discussed with relative incharge / Departmental Head to remove that short coming.
4.2. If the production department takes no action on verbal intimation that particular thing will be “HOLD” by affixing red specified label of “HOLD” which means to stop that “thing” (already defined).as and where it is.
4.3. After “HOLD” the particular thing should be Segregated/Removed from that place into safe custody of either Production / Q.A Department.
4.4. In case of “HOLD” it is responsibility of QA department to intimate relative Incharge in Written and to give suggestion, advice or direction in that particular mater, and to direct relative department to submit the reasons in written about that particular matter.
4.5. In that particular “thing” which is under “HOLD” will be released after the submission of written acceptable justification by relative department.
4.6. If the matter will remain disputed, meeting of all departmental heads will be called to resolve the matter.
4.7. Finally the matter will be brought into the notice of Director Operation /Chief Executive and they are the the supreme authority to make any decision.
5.0 RECORD REQUIRED:
The following record shall be generated in accordance with “HOLD” procedure:
Required Record Form Reference No.
HOLD sticker QF/070/01
Interdepartmental memo QF/028/01

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