Standard operating procedures sops is a written procedure for any process or system that is followed during the operation of any system or equipment. Standard operating procedures sops need to be written from a technical perspective. Good documentation practice in pharmaceutical industry. Employee personal file sophr004 employee personal file page 3 of 6 a signed copy of the acknowledgement page of handbook. Before knowing the interview questions for qa job, you have to know the situation in interview pattern. This article mentions about effective sop training, cgmp and on the job training where a trainer can judge and plan for retraining for the. Sop for product recall in pharma sop for product recall in pharmaceutical industry published by pharmastate blog this is a platform for people working in the pharmaceuticals industry for.
We use cookies to offer you a better experience, personalize content, tailor advertising, provide social media features, and better understand the use of our services. A standard operating procedure sop is a set of written instructions that document a. For example, the purpose of this standard operating procedure sop is to specify the processes used to manage sops. A typical pharmaceutical industry has an average of 1200 0 sops. Gmp, good manufacturing practice, sop quality documents. Officer or abovewarehouse is responsible for receipt of raw materials and packing materials.
A who guide to good manufacturing practice gmp requirements. This procedure shall be applicable for handling of out of trend of stability sample at quality control. Clinical project managers, monitors and assistants in the pharmaceutical industry. Sop on handling of out of trend oot pharmaceutical. Sop on issuance, preparation, storage, usage and disposal of disinfectant solution. This standard operating procedure is applicable for the control of documents and documented data at the formulation plant of pharmaceuticals company name with location. Quality assurance interview questions in the pharma industry. Complexities of record keeping in the pharmaceutical industry, there are inherent. A parenteral drug association pda survey found that a typical pharmaceutical. Sop on handling out of trend oot results pharmastate blog. Quality assurance of pharmaceuticals world health organization. Pharmaceutical quality assurance manuals and validation.
Sops for pharmaceuticals related to quality assurance, quality control, production, maintenance, utility and human resource are listed here. Pdf standard operating procedure sop for pharmaceutical. In the food, drug, and medical device industry it is critical that good procedures are in place to ensure a controlled and consistent performance. Download free sop for gowning procedure in pharma pdf. There is a broad range of sops needed for a pharmaceutical manufacturing establishment. Standard operating procedure for handling the change control in pharmaceutical manufacturing facility. Sop on document and data control pharmaceutical guidance. How to write standard operating procedure sop this is not an approved copy unless stamped in red file location. To lay down a procedure for receiving the raw materials and packaging materials. This sop is applicable for receipt of raw and packing material to warehouse of pharmaceutical. This standard operating procedure is applicable for the control. Sop for assigning of identification numbers to equipments, subequipments. Follow established standard operating procedures sops.
United states office of environmental agency washington. If unavoidable, appropriate justification and documentation should be in place. To lay down a procedure for handling of out of trend for stability sample. An sop is a procedure specific to your operation that describes the activities necessary to complete tasks in accordance with industry. After completion of the master formula working record mfwr. Sop for environmental monitoring of manufacturing area by settling plate. Sop on document and data control complete pharma solution. The objective of this standard operating procedure is to describe the actions required to. Through the provisions of this procedure, a proposed change shall be evaluated and approved internally on its scientific merit and appropriate external authorization shall be sought for those changes that impact on regulatory submissions.
All associates have the responsibility of ensuring that all gmp activities are performed according to the official sops. Good documentation practice in pharmaceutical industry eudralex vol 4 a blog about pharmaceutical quality control, quality assurance, microbiology, production and. A standard operating procedure sop is a set of written instructions that document a routine or repetitive activity which is followed by employees in an organization. Pharma sop, standard operation procedures, standard. Purchase the most important quality good manufacturing practice gmp document templates for active pharmaceutical ingredients api and drug product and device manufacturing. Guidelines writing standard operating procedure for pharma industry sop pharma. Process improvement in pharmaceutical industry through kaizen lean methodology kaizen institute pedro maria parreira jonet department of engineering and management, instituto. Gmp manufacturing sop quality assurance qa and compliance. Clear and concise avoid writing wordy sentences or using. This procedure applies to handle the change control at the manufacturing facility.
It is also acceptable not to apply oot for certain test parameter or product if. To lay down a procedure for the preparation, approval, authorization, control and revision of standard. Hplc calibration gmp sop operation, calibration and maintenance of electronic analytical single pan balances aseptic technique guideline for manual operation in a biological safety. All hods shall be responsible to follow this sop for maintaining control on all documents. Guidance for preparing standard operating procedures sops. Standard operating procedure in pharmaceutical industries. Sop for quality management system documentation in. Head warehouse shall be responsible for compliance and. Pharmaceutical and biotechnology companies typically. Standard operating procedure in pharmaceutical industries,sop,mfr,master formula record, how to write sop, sop content, mfr content 1. Guidance for preparing standard 30 to ensure that approved procedures are followed in compliance with company and government regulations. Standard operating procedure public sopema0083, page 36 outsourcing. Eye protection face shield nonlatex gloves heavy black rubber gloves 6 long forceps or tongs.
Sop 11 sponsor responsibilities in investigator initiated studies keywords investigator initiated, gcp sop, instructions, sop, standard operating procedure, research ethics and governance. Good documentation practices gdps in pharmaceutical. The purpose statement needs to be detailed enough so that the intended user can recognize what the document covers. The guideline offers a systematic methodology to industry for developing high quality generic fpps, which are consistently pharmaceutically equivalent to the innovator comparator. Survey appraises the use of sops in clinical research from the sponsors point of view. Sops for pharmaceuticals related to quality assurance, quality control, production. Procedures are essential for any plants effectiveness and efficiency, and they are regulatory requirement in the pharmaceutical industry. A list of standard operating procedure for pharmaceutical quality assurance department required during quality system. Site master file skopje, 2010 smf 01 page 2 of 38 goce delcev 12. Standard operating procedures sops, pharmaceutical industry i. Standard operating procedures are documents written to perform specific tasks or activities in an organization. Standard operating procedures sops, inconsistent documents, nonvalidated electronic systems, noncertified copies, poor correction practices etc. Deepa godhiya 14 rashmi meher 06 ravi khatpe 31 ruchir gandhi29 table of contents introduction to sop. This sop is applicable for receipt of raw and packing material to warehouse of pharmaceutical formulation plant.
To establish a procedure for controlling and documenting changes. An sop as defined by wikipedia is a set of stepbystep instructions compiled by an. Sop 11 sponsor responsibilities in investigator initiated. To lay down a procedure for control of documents and documented data. Having a set of operating standards defined through quality documents. Gmp guidelines and regulations for pharmaceuticals, sterile. Standard operating procedures sops are issued to specifically instruct employees in areas of responsibility, work instructions, appropriate specifications and required records. Process improvement in pharmaceutical industry through. Document owners are required to ensure that all aspects of documentation and records management specified in form of standard operating procedures sops. Sop for line clearance in manufacturing area standard operating procedure to ensure line clearance before starting the activity in manufacturing, filling and packing area.
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