In present scenario many pharma companies face the problem of “483” from FDA within India and also from USFDA which is why many established companies are facing ban and threat in the form of warning letters. But one can combat situations like these by following simple rules and maintaining good manufacturing practices.
Introduction:
In the world of “Pharma” safety is synonymous to everyday activity performed in the laboratory or manufacturing premises. Advanced machinery is used in the facility costing lakhs of rupees which are designed to handle potentially harmful products. Therefore safety measures are to be taken as they need to be handled with great precision.
Safety precautions are to be followed without compromise. The company should make the employees aware about the clearing procedures like fire extinguishers, area for washing eyes, and equipment with “emergency stop” buttons. Cleaning or maintenance of steam lines, tanks, vessels and lyophilizers and tag out, lockout and work order procedures should be followed strictly.
Below are the ways to avoid GMP errors:
1) Hygiene – Washing hands is the primary rule to be followed before entering work area. If not followed then it may lead to contamination by bacteria which makes the batch of medicines failing standards and substandard efficacy or adverse effects.
2) Cleanliness – Floors and equipment should be kept clean by adapting to approved procedures for cleaning. Using of procedures that are not validated results in failure of cleanliness. Every equipment should be checked for cleaned equipment tag and logbook. It is advisable to check the equipment for any left solvent which has not been rinsed.
3) Health – If any employee suffers from sickness he should report to concerned department to replace him with a temporary employee. Meanwhile that time can be allocated to learning new things like standard operating procedures, GMP guidelines or etc.
4) Personal protection Equipment (PPE) – Personal protection equipment like shoes, goggles and respirators should be worn by the personnel in the facility. One mistake that is overlooked is not wearing safety goggles. Material safety data sheets should be read by the personnel for all materials.
5) Personal safety – Personnel working should always be on alert and trust their instincts to eliminate potential hazards. Employees are prone to certain injuries due to improper knowledge on certain techniques. Guidance of supervisors should be mandatory.
6) Attire (Within Premises) – On the Job training should be given so that employees follow proper attire like sterile gowning. Later such practice should be supervised by the concerned department. Many people don’t wear their lab coats or hoods or covers for their shoes in laboratory. Certain designer dresses should not be worn in bulk drug units.
7) Attire (Outside Premises) – Employees visit wash room with the lab coats or uniform and at times go out of the plant with the same uniform and smoke. Certain women also use jewellery that is not permitted in certain plant areas. Caution should be taken in this regard.
8) Environment – In work premises most fatal accidents take place during breaks or when the person is tired or out of the working area like in lunch time or changing shifts. In such conditions the work should be properly handled or instructed to another coworker or supervisor to avoid accidents.
9) Planning – Good manufacturing practice can be hampered when employees go to work with limited thought of action. There is more chance of deviation when things are done with limited or no planning. Hence proper management should be followed.
10) Time management – Even when employees are told proper instructions but still fail due to improper time management or rushing things.
11) Organizing – Sometimes a single employee may need to handle multiple tasks like monitoring different equipment’s then the employee may seek guidance in doing his work or should properly organize so that no discrepancy occurs.
12) Procedures – Standard operating procedures (SOP) and any other material related to work should be properly understood by the employees. Proper review should be done to notify any changes that need to be done as per SOP under direction of supervisor.
13) Use of authorized materials – Only authorized and approved materials should be used. From starting materials to labelling and packing materials only approved materials should be used. Expired materials should be removed from time to time and destroyed. Proper segmentation should be there so no expired material is mixed with other materials.
14) Calibration – Every equipment should be calibrated properly and thoroughly checked. The date and the person who has calibrated it should mention the details with a tag.
15) Segmentation – raw materials to finished products should be given unique identification numbers to avoid confusion and help in finding the product easily. Lot number, sample and its reference sample with their document and revision numbers should be noted.
16) Documentation – Documentation is the key process and many companies are facing threat of ban due to improper practices. Every blank in the document should be filled with correct information. If sufficient evidence is not available or it is not applicable wholly then it should be written as N/A along with its initials and date. If sections or pages are not adequate then write it as N/A along with your initials and date. If the corrected information is not entered into the records or log book and result form then it may result in incomplete documentation.
17) Maintenance of records – Entries should be recorded one at a time but not all at once as human is bound to forget few things and may enter a wrong reading. Employees entering the readings should be trained to note accurate readings and maintain lab records and results form.
18) Record Keeping - Handwriting in the record should be clear and legible. If the employee doesn’t have a good handwriting then the document should be printed. The printed form should be clear in logs and completely filled.
19) Indestructible ink - The standard color or ink to be used is blue or black indestructibel ink as it is easy to photocopy and doesn't produce smear. Pencil is not acceptable as it can be erased besides producing graphite matter which is hard to be controlled.
20) Correction fluid - It is prohibited to use fluid to correct the readings with correction fluid.
21) Record changes - If any change is to be made then a line should be drawn through error by using indestructible ink and stating the correction above with date and initials.
22) Data manipulation – The records should not be falsified. Every record or change or data being entered should be done along with date. When any data that is entered without date is considered to be manipulated. If a supervisor checks in middle of work then it need to be notified in the comment section.
23) Copying data – Data should not be copied likewise noting the original data on scrap book or napkins or tissue paper and copying from it later. If at all it is noted on any other paper then it should pinned to the record as it contains original data. Original data should not be discarded.
24) Out of specification results – Results should not be averaged to get a passable result. Every company should have a particular procedure as to how to test samples and handle results. If anything goes wrong during the process then the employees should be encouraged to tell the deviations.
25) Document review – Document should be properly checked so that no records or data are missing. Calculations and data should be checked for accuracy and precision. After thorough review only the document should be signed.
26) Secondary review – Double checking should be done and it is noted that checking should be done another person. Crucial process like adding and weighing materials should checked twice as they are more prone to have discrepancies. Proper trained staff should be in sufficient number so that when one person does the work another checks and suggests later the record is to be signed.
27) Labelling – labelling should be done properly. Any expired product should be labelled according to its condition to dispose or discard. Any change in the process of labelling may reflect that the product has been changed; thereby any changes should be notified to the concerned department.
28) Closing the doors – In the facility sometimes when personnel move into and out of the facility the doors may remain opened. This gives a chance for all the insects and animals to come in for shelter or for food and water. Even gap of 0.25 inches are enough to let the rat come in so the gaps should be considered while constructing.
29) Notifying errors – Once the mistake is identified then steps should be initiated to correct it by notifying to supervisor. Supervisor should encourage staff to notify things rather humiliating them.
30) Correcting errors – When a mistake occurs then the concerned department head should look deeply into the issue and see that it is not repeated. Instead of expecting for ideal work the supervisor should train the employees.
31) Eatables – Any kind of food items should not be brought into the premises as such practices are prone to cause failure of GMP. Drinking, smoking or eating is prohibited the facility. Food in the facility invites many insects and rodents which can later settle on pallets.
32) Pest control – Devices for pest control should be checked with its identity number and its location. Pest control should be checked by placing a plastic mouse in traps. Traps should be placed alongside the walls as rats run by walls. Antidotes should be kept in hand in case of necessity.
33) Audit – During audit or inspection answer every question with honesty and for further clarifications or unanswered questions refer to the department head. Information should not be concealed either good or bad.
Apart from above said ways a good team work and loyalty towards company are necessary to maintain the ethics of the company.
Quality assurance, gmp, safety
