Standard operating procedures

This slide includes:
Standard Operating Procedures (SOP) - its definition, types, needs, method of SOP making, General Areas Covered by SOP in a Pharmaceutical Industry, Do's and Don't while making SOP definition and types of parenteral preparation in BRIEF.
The questions added at the end of the presentation is based on the asking pattern of CSVTU, Bhilai.

1. STANDARD OPERATING PROCEDURES.(SOP’s). PREPARED BY - PRIYANKA PRASAD M.PHARM. RCPSR, BHILAI.

2. Contents introduction ----------------------------------------------------------------- 1 why is it essential------------------------------------------------------------- 2 FDA's three golden rule on documentation------------------3 AIMS----------------------------------------------------------------------------------4 general areas covered by sop---------------------------------------5 types of sop’s---------------------------------------------------------------6&7 SOP WRITING STYLE--------------------------------------------------------------8 CONTENTS OF SOP---------------------------------------------------------------9 PROCESS OF SOP---------------------------------------------------------------10 parenteral preparations------------------------------------------------11 SOP FOR FILLING OF AMPULES---------------------------------------12 &13 DO’S---------------------------------------------------------------------------------14 DON’T’S-----------------------------------------------------------------------------15

3. Introduction : A standard operating procedure ( SOP) is a  set of step-by-step instructions  compiled by an organization to help carry out complex routine operations. Standard Operating Procedures (SOPs) are essential for any plant’s effectiveness and efficiency, and they are a regulatory requirement in the pharmaceutical industry KEYWORDS : SOP – Standard Operating Procedure Step – by – step instructions. For effectiveness and efficiency. BACKBONE OF EVERY PHARMACEUTICAL INDUSTRY .

4. Why is it essential? The manufacturers of health care products rely on precision, rigor and consistency to produce reliable products for patients, physicians and consumers, time and time again. To drive the kind of culture that consistently and effectively produces results of this nature, companies must first create a culture where quality objectives are transparent, well understood, and acted upon routinely, and thus the need to develop a well maintained record of every correct procedures carried out came, which was known as Standard Operating Procedures (SOP’s).

5. FDA’s three golden rules on proper documentation If it isn’t written down, it didn’t happen. If it isn’t written down properly, it didn’t happen either. Never forget Rule 1 and 2.

6. AIMS. To maintain the equilibrium in quality control and quality assurance. The purpose of an SOP is to carry out the operations correctly and always in the same manner. Uniformity of performance. To serve as a reference for teaching purposes about the process for which the SOP was written. It should be available at the place where the work is done. Elevate the status of pharmacists and enhance their motivation for better performance. Reduce miscommunication and failure to comply with industry regulations. To provide guidelines for accurate and on time data collection.

7. GENERAL AREAS COVERED BY SOP SOP for Drug Lists. SOP for handling of equipments in laboratories/ industries. SOP for Procurement of Medicines SOP for Receiving Drugs into Pharmacy SOP for Drug Storage SOP for Vaccine Storage SOP for Temperature Control SOP for Issue and Delivery of Drugs to Dispensary/Satellite Pharmacies/Wards /Other Units. SOP for Dispensing. SOP for Patients Counselling

8. Continued…. SOP for Procurement, Dispensing and Distribution of Narcotic Drugs and Poisons. SOP for Disposal of Expired Drugs SOP for Clinical Ward Round SOP for Training of Intern Pharmacists SOP for Continuing Education SOP for Drug Revolving Fund (DRF) Scheme SOP for Drug Information Service (DIS)/Drug Information Centre (DIC). SOP for Dress Code SOP for Therapeutic Drug Monitoring (TDM) SOP for Screening Prescriptions SOP for Preparing a Drug Formulary. SOP for counselling of Handicapped Patients SOP for Compounding of Medicines

9. TYPES OF SOP’s Fundamental SOP : These gives instructions how to make SOP’s of other categories. Methodical SOP : These describe a complete testing system or method of investigation Analytical method Preparation of Reagent Quality Assurance For operating instruments, equipment and apparatus Safety & Precautions Receiving and registration of sample To deal with complaints

10. Sop writing style: SOP’s shall be written in a concise, step by step, easy to read and follow format. Information should not be complicated. The active voice, and present verb tense should be used. Should be simple and short. Routine procedures that are short and require few decisions can be written using simple steps format. Long procedures consisting of more than 10 steps, should be written along with graphical format or hierarchical steps. Procedures that require many decisions should be written along with flowchart.

11. CONTENTS OF SOP Company name and pagination Title Identification Review and approval Purpose Scope Responsibility Procedure

12. Process of sop SOP Preparation SOP Review and Approval Frequency of revisions and reviews Implementing SOP Management of SOP

13. Parenteral preparations: Parenteral term is derived from Greek word Para meaning Outside , and Enterone meaning Intestine. Parenteral preparations are sterile preparations containing one or more active  ingredients  intended for administration by injection, infusion or implantation into the body. CLASSIFICATION :- Parenteral preparations are of 2 types:- Large volume parenterals. Small volume parenterals.

14. Sop for filling of ampules Make sure that the filling area has been cleaned properly. Switch on the laminar flow and make sure that it has been wiped with 70% IPA. Feed the ampoules to an inclined charging hopper. The ampoules are passed continuously through rotating feeding wheel to the conveyor. The ampoule conveyor carries the ampoules vertically at an angle of 300. Pass nitrogen(inert gas) into empty ampoules.

15. Continued… The volume to be filled passes through the pumps into the ampoules. Again pass the nitrogen into the filled ampoules. The filled ampoules are moved to sealing station for sealing. Make sure that the sealing has been done before the inert gas can diffuse out. Collect the sealed ampoules through the collection hopper and send for labelling.

16. do’s Write in present tense. Don’t use past tense, condition of future tense unless you have good reason to do so. Avoid ambiguity and be concise. Reduce the word count where possible without changing the meaning of the text. Keep the words short and get to point. Highlight exceptions. Use a symbol to flag that this is an exception and how to handle it. Highlight warnings and use a larger or a warning icon.

17. Don'ts Introduce acronyms without explaining what it means. Don’t use the word “ may “, “ if possible” as it implies that the user can do something under conditions. Instead be positive and tell them what to do. Because SOP’s are a set of INSTRUCTIONS , not CONDITIONS .

18. Questions frequently asked:- SHORT NOTES: Standard Operating Procedures for parenteral preparations. {OR} SOP of any one dosage form. {OR} SOP.

19. THANK YOU