Quality assurance is the key department in the pharmaceutical industry. Quality assurance (QA) is the central point of all activities performed in a pharmaceutical company, all working go through the QA department’s approval like research, Raw Material Store, quality control, manufacturing, and sales. QA ensures the pharmaceutical products are manufactured to a safe and consistent standard quality. QA department is responsible for allowing a range of practices that results in a quality product manufactured. Pharmaceutical companies effort to manufacture high-quality products to maintain their reputation and increase their profit, and to serve the best quality medicines for mankind. The role QA is to meet all aspect of Pharmacopoeia standards and produce a product which is up to the mark of all parameters in quality checkups.
Role of Quality Assurance in Pharmaceutical Industry
Quality Assurance has a wide role in the pharmaceutical manufacturing Company. In a pharmaceutical manufacturing company all working starts and end at the quality assurance level, As per laid SOPs in the company nobody is allowed to work out of SOP, and the SOPs are fully controlled and implemented by QA. Here all functions of Quality Assurance are given in details:
Quality Assurance role in raw material store
All incoming raw materials, APIs, Excipients, Dissolvent’s, Chemicals are primarily verified by QA department personnel, they will check thoroughly the bill number, batch number, mfg. date, expiry date, Vendor’s details, manufacturer’s details whether the container is intact in packing seals and labels. If all parameters are passed in visual inspection then the material proceeds to the next step which is a sampling of the same.
The sampling process is done under the supervision of QA department personnel’s along with Quality Control personnel and Store in charge. The Raw material will be quarantined until the sample report of testing does not generate.
Quality Assurance role in Quality Control
Quality Assurance has parallel liability in the quality control department along with QC. In the QC department every testing procedure start following the SOP issued by QA, the supervision of QA is to be maintained continuously on all analysis activities.
QA has a liability to issue SOPs for all activities along with the operating procedure of all instruments in the quality control department. Validation of all testing procedures and instrument performance is also QA’s responsibility. QA in a prescribed time period performs validation of processes and equipment performance’s validation.
Quality Assurance role in Production
Quality assurance has a vital role in the production department of any pharmaceutical manufacturing company. To provide SOPs for the manufacturing processes and SOPs for machinery operating is also QA responsibility. Every manufacturing process has a Master formula for different products, compositions, and dosages. To create Master Formula for manufacturing processes is the QA department’s liability.
Manufacturing of any batch starts with QA department clearance for machinery usage after their proper cleaning reports approval. QA also engage while raw materials weighing process. QA department cross-checks every active and inactive ingredient before the production of products.
All in-process checks like weight variations, friability test, Disintegration test, dissolution test, volumes check-in liquid, ph of liquid batches are inspected by QA personnel. A complete manufacturing process is
QA system has to perform the following functions
- All Incoming containers of RM, Packing materials, Components in the warehouse or Store
- All productions record and review them periodically
- Process control and inspections
- All manufacturing process and in-process checks during production
- Release of every batch manufactured with due record process
- Maintaining warehousing storage of finished goods
- Reviewing product by stability and self-life evaluation of finished products
- Complaints handling
- Drugs related all liaisoning jobs
- Handling of change of control system
- Internal quality inspections and system reviews
Training of technical and supporting staff
Training is one of the most top priority tasks of QA. Every newcomers and old chemist staff need training in the latest and updates in the pharmaceutical industry. Regular training programs provide them clarity on their duties and functions of machinery.
Personnels are trained in different phases e.g.
- Initial training at the time of induction
- Refresher course at every 12 months
- Seminars, Conferences, Workshops for executives/managers as and when actually conducted by different institutions like IPA, OPPI, Chamber of Commerce, etc.
The main training program is that, which conducted at the time of induction that is the initial training. This conforms three stages
- Lecture session
- Shop floor demonstration
- On the line orientation at shop floor level
The lecture session is conducted for a period of three days, where the staff is trained in groups. They are told about the different type of Job Operation categories e.g.
Best Handbook of Pharmaceutical Quality Assurance
ENGINEERING / UTILITIES
Different machine operations, cleaning & lubrication checkpoints to assess would be faults, maintenance, etc.
STORE / MATERIALS / PURCHASE
Organizing of store/stocks, maintenance of records of material/issue, selection of vendors, etc.
Security, safety, attendance of staffs and workers, leave register etc.
The lecture session is followed by a shop floor demonstration, where the persons are actually brought to the shop floor in groups and shown the machinery operations / other operations etc. Normally it is done for two days but in case of any necessity, the number of days can be increased.
For demonstration mainly technical managers/executives and supervisors/workers from all categories are given orientation. In the case of workers and supervisors, everybody is given special attention for at least two functions e.g.
Product / Q.C. : Production Plant & Laboratories
Engineering : Maintenance, Plant operation
Purchase / Administration : Administration, store operation and purchase
On the line shop, floor training is the final stage of initial training which is conducted for at a stretch for 6 days (a whole weak) and if required for another 6 days. By the time the trainee comes to the level, become acquainted with the training faculty and demonstrators, so some assessment of the candidates has already come up. On the basis of that, the shop floor orientation has designated that means who will take which training. In the case of production and engineering workers at least 6 machines, each is dealt with. In the case of other workers like Q.C.D & stores they are mainly entrusted with glassware cleaning/salting and material handling.
SOP Development by Quality Assurance maintains a master SOP OF SOP.
1 Give the small title to each SOP at the top.
2 Mention the date of printing of SOP at the right top corner.
3 Mention the SOP No. / Doc No. below the date of printing.
4 Mention the total no. of pages below the SOP No. in sequence.
5 Mention the current revision no. below the page no.
6 Mention the Step-wise detailed procedure of each operation
7 Attach relevant format with each SOP for the compliance documentation.
8 Special precautions if any, to be taken while following the SOP should be marked separately before the end of SOP.
9 In the end mention the reason of revision of SOP.
10 All the SOP’s shall be signed in blue ink pen by the personnel responsible for making SOP’s in the respective column with their designation & name in capital.
11 Mention the effective date in the respective column.
12 Mention the review date in the next column after two years of effective date.
13 Mention clearly the policy of making SOP.
14 Mention the designation of key personnel accountable for the operation.
15 Once in a year or as needed.
16 In S.O.P. mentioned what is your supporting document for SOP compliance
Quality Assurance is a key department in a pharmaceutical manufacturing company, without QA it is not imagined the quality product output from any pharmaceutical manufacturing company. In fact, quality assurance should be set up before start manufacturing in the company because QA has to prepare lots of documents to guide the manufacturing process.
Quality Assurance provides a disciplined atmosphere for manufacturing and other activities in a manufacturing company. QA delegates responsibilities to every person in the company.
Strong Quality assurance can guarantee quality product output from the manufacturing company. QA plays the role of FDA envoy in manufacturing site who ensure a product which complies all quality parameters. It should free from all internal and external pressures, let them work to improve the quality of products.
The author has 20 years of experience in the Pharmaceutical Manufacturing Companies. Have exposure to all audit documents for WHO-GMP, PIC/S, USFDA, Export documents, US-FDA documents, Validation of Pharma machinery, and Quality Control Instruments. Expert in Pharma Plant Setup and sale and acquisition of running pharma company.