SOPs

Standard operating procedure: 

By MRS. CHETNA D. MODI Asst. prof . SKIP, Shankhalpur Standard operating procedure

For best quality medicines: 

Right quality Right quantity Right price To ensure highest standards of drug products Applicable to GMP requirements For best quality medicines

WHY?: 

FACTORS AFFECT QUALITY OF DRUG PRODUCTS Storage and handling (material & equipment) Manufacturing process and environment Quality control lab testing procedures WHY?

SOPs: 

They enable the people to perform the task accurately and without mistakes IF IT IS NOT WRITTEN, IT IS NOT DONE SOPs

Defination : 

SOPs is a documentary evidence of a process in form of ‘who’, ‘what’, ‘when’, and ‘how’. Which clearly identify responsibilities and action steps associated with a process or a portion of process. D efination

Advantage : 

A dvantage Promotes quality through consistent implementation of a process within a organization. Personnel training program, Detailed work instructions, Minimize miscommunication, Historical data for current use, As a reference for reconstructing project activities, As a checklist for inspectors at the time of audit, Process improvement

Contents of SOPs: 

Contents of SOPs Objectives Procedure to be followed Person responsible for doing activity Person responsible for checking/supervision Frequency of activity Name of company SOP number Revision number Reference Concern department Recipients (if any circulation to outside dept.)

SOP for SOPs: 

SOP for SOPs Company has to make and include What kind of information Structure and format Numbering system Time frame for revision Authorized person for doing such activity like creating , checking, verifying, implementing

Detailed content of typical SOP (for process): 

Detailed content of typical SOP (for process) List of material & components required for process Description of compounding of reagents required List of equipments required and their relevant features like capacities, precision, compatibilities and limitations. Step wise description of process to be performed Process control parameters with testing limits/acceptance criteria Test methods Reporting and documentation required Technician training reqm .

Detailed content of typical SOP (for equipment): 

Detailed content of typical SOP (for equipment) Set up Assembly Operation Disassembly Cleaning Maintenance Validation Calibration One team for QC One team for QA

WRITING STYLE: 

WRITING STYLE Depending on the user’s reading ability At operational areas 7 th grade level At professional staff areas 10 th to 12 th grade level In concise, step-by-step, easy to read format. Not be wordy and lengthy (more words– more argue) Use Active voice and present verb tense Use active tense (assemble the centrifuge tube in centrifuge) We look at first several words, skip the middle and read last 3 to 4 words. So put information at start and end statement.

SOP format: 

SOP format

Slide 15: 

Title: Operation of DIGITAL INDOOR/OUTDOOR HYGRO-THERMO CLOCK (DHTC) SOP No: SKIP/ANI.HOUSE/DHTC/1/1 Department: Pharmacology Laboratory Page 1 of 2 Effective Date: 25/10/2010 Supersede No: -00- Review Date: After 1 year SHREE KRISHNA INSTITUTE OF PHARMACY, SHANKHALPUR Standard Operating Procedure Prepared by Approved by Signature Name Mr. A.B.Desai Dr. A.R.Shah Date OBJECTIVE AND SCOPE It is used to define a procedure for measurement and control of humidity and temperature of animal house. This will ensure that SOP prepared for the handling of digital hygro -thermo clock will serve as guidelines to the initiator of this instrument. RESPOSBILITY Operation: faculty, and students Maintenance: lab assistant Cleaning: peon. ACCOUNTABILITY Head of department/ faculty incharge Principal: INTRODUCTION Single display show in/out door temp. and humidity. Memory function to recall max/min reading. Tell you indoor condition by showing comfort, dry, weticon . Automatic update max/min temp. /humidity memory. Instant 0 F/ 0 C switchable. Table or walls mount design. IN temp. range:- -10 0 C to +50 0 C/+14 0 to + 122 0 F OUT temp. range:- -50 0 C to +70 0 C/+58 0 to + 158 0 F HUMIDITY range: 20% to 99%. Accuracy: ±1 0 C or ±2 0 F; ±5%. Resolution: 0.1; 1%. 0 F/ 0 C button to select the temperature unit. MAXIMUM & MINIMUM TEMPERATURE HUMIDITY MEMORY DISPLAY Press [MAX/MIN] to display maximum temp. & humidity memory (MAX symbol will be displayed). Press [MAX/MIN] again to display maximum temp. & humidity memory (MIN symbol will be displayed). Press [MAX/MIN] again to take instant temp. & humidity reading. Press reset button to clear memory. CLOCK ADJUSTMENT Press & hold “MODE SET” button about 2 seconds the (12h or 24h) will be flashing then press the “MAX/MIN” to select (12h or 24h). Then press the “MODE SET” again the hours will be flashing then press the “MAX/MIN” to adjust the hours and press the “MODE SET” again the minute will be flashing then press the “MAX/MIN” to adjust the minute. Press the “MODE SET” again to leave this adjustment mode. ALARM ADJUSTMENT Press the “MODE SET” once the “AL” will be shown on display. Then press and hold 2 seconds “MODE SET” again the hour will be flashing then press the “MAX/MIN” to adjust the hours and press the “MODE SET” again the minute will be flashing then press the “MAX/MIN” to adjust the minute. Press the “MODE SET” again the “AL” will be shown on display then press and hold 2 seconds the “AL/SNZ” the alarms switch on. Press again and hold 2 seconds to switch off. Press the “MODE SET” again to leave this adjustment mode. ABBREVIATIONS SOP: standard operating procedure No: number REFERENCE From instrument manual. Part of title page Part of title page Text

List of SOPs: 

List of SOPs Process Equipments Manufacturing of Tablet Coating of tablet Packaging of tablet Filling of capsules Packaging of capsules Manufacturing of semisolids Packaging of semisolids Manufacturing of liquids Packaging of liquids Manufacturing of parenteral products aceptically Packaging of sterile products Packaging of ophthalmic preparations Fluidized bed dryer Rotary tabletting machine Colloid mill Planetary mixer Ampoule filling/sealing machine Bottle filling/sealing machine

Slide 17: 

Happy diwali