SOP for Basic GMP Requirements in Production Area

Learn how to write the Standard Operating Procedure (SOP) for basic GMP requirements in production area, ensuring quality and compliance in pharmaceutical manufacturing environments.

1. PURPOSE

To describe a basic rules for Good Manufacturing Practices to be followed by each and every employee working in the production area.

2. SCOPE

This procedure is applicable for establishment of basic GMP requirements of all production areas in this pharmaceutical.

3. ASSOCIATED DOCUMENTS

Good Manufacturing Practices (GMP) Guidelines

4. PRECAUTIONS

Nil

5. RESPONSIBILITIES

5.1 All personnel of QA and Production shall follow the guideline of GMP.

5.2 Head of concerned department shall be responsible to follow up the implementation of GMP.

5.3 Head of Quality Assurance is responsible for supervision overall job.

6. ACCOUNTABILITY

Head of the Quality Assurance Department

7. PROCEDURE       

7.1 All persons working in the facilities of company shall practice good housekeeping all the time.

7.2 A head cover, facemask and protective cloth (as defined for the production floor by the authority) shall be worn by anyone entering into production areas.

7.3 Company shoe shall be put on before entering production area. Uniform shall be changed only in the change room. Personal shoe shall be kept in the locker or outside face of the shoe rack.

7.4 Hands shall be washed before starting the day’s work and after every break period and also while coming from the toilet.

7.5 Protective cloths & rubber shoes have to be cleaned at every 2 days/ Product change & at 7 days interval respectively.

7.6 All personnel shall practice good personal hygiene while on the premises.

7.7 All exterior doors shall be kept closed to control the entrance of dust and insects.

7.8 Eating and drinking, chewing or smoking or the storage of food, drink, smoking materials or personal medication in the production and storage areas shall be prohibited.

7.9 Vacuum cleaners should be dedicated for specified area or for product bases on product nature.

7.10 Spills of products/materials, whether powder or liquid shall be cleaned immediately to avoid tracking that material into other areas. Contamination of powder spills and dusts shall be vacuumed up immediately to minimize further contamination, which occurs with sweeping or ducting.

7.11 Workstation and machine shall be cleaned and record shall be maintained by operating personnel at the end of each shift/ day/product.

7.12 All machinery shall be used according to their specifications. Under no circumstances integral parts from one piece of equipment shall be used in other.

7.13 Cleaning accessories must be kept in hang & not touch on floor.

7.14 All equipment shall be maintained as to ensure uniformity and accuracy of production. They shall be provided identification of the product under the production.

7.15 Containers of all products/materials shall be tightly closed when not in actual use. This includes tying off polyethylene bags with adhesive tape and locking drums with properly fitted covers.

7.16 All containers used for bulk products or dispensed materials, must be cleaned after using each bulk products or dispensed materials following SOP.

7.17 Carton/ drums holding packaging components shall be sealed with tape when not in uses in  order to keep contents as clean as possible.

7.18 All cartons and drums holding intermediates, raw materials or packaging components shall be clearly and completely identified with product name, code ( if possible), batch number and quantity.

7.19 Waste containers shall be provided in specified locations and with clear identification. Containershall be always covered. It shall be clean after disposal of waste material.

7.20 Wooden Mop, flower broom & fiber shredding cloth must not be allowed to use in production area.

7.21 Employees working over open product must wear gloves. Safety goggles shall be put on where ever necessary.

7.22 Blue ink must be used for signature and date in all documents and records. For Example: SOP, Protocol, COA, BMR, BCR and BPR etc.

7.23 If it becomes necessary to correct a miss-entry or error, made in hand inscription of a number or an entry on any document related to the operations, it is required that this shall be done in only one acceptable manner like:

7.23.1 Strike a single line through the error.

7.23.2 Date and initial the strike out.

7.23.3 Write the correct entry.

7.23.4 Specifically prohibited in correcting such errors are:

       –  Use of correction fluid (“White out”

  – Strike over

– Obliteration of original error.

– Water soluble pen

  – Pencil and Eraser etc.

7.24 Line clearance shall be ensured before start of operation. In process control check shall be Carried  out as per schedule mentioned in BMR/ BCR/BPR.

7.25 Any deviation from instruction or approved procedure shall be avoided as far as possible. If a deviation occurs, it should be approved in writing by head of quality assurance.

7.26 Status label shall be ensured at all stages of operation. Room shall be identified with an identification of product, batch no, strength and stage of operation.

7.27 Label affixed shall be clear, unambiguous.

7.28 Checks on yields and reconciliation of quantities shall be carried out as necessary to ensure that there is no discrepancy outside acceptable limits. Any significant variation shall be recorded and investigated.

7.29 Intermediate granules, bulk and finished products shall be physically and administratively quarantined immediately after processing, until they have been taken/ released for next step.

7.30 Physical segregation shall be ensured during storage of products waiting for recovery or reprocess.

7.31 Dispensing, overprinting and operation of different product shall not be carried out simultaneously or consequently in the same room unless there is no risk of cross contamination or product mix-up.

7.32 Starting material shall only be dispensed by designated persons, following a written Procedure to ensure that the correct and released material are accurately weighed or Measured into clean and  properly labeled container.

7.33 Each dispensed material and its weight or volume shall be independently checked and recorded in BMR/BCR/BPR.

7.34 Materials dispensed for each batch shall be kept together and conspicuously labeled as such.

7.35 All batch coded excess packaging materials shall be destroyed immediately at batch packaging end.

7.36 Rejected products shall be clearly marked as such and stored separately in restricted areas.

7.37 Production area shall be dry, cleaned frequently. Production department shall ensure cleaning of  machine and machine rooms at day end and during product change over.

7.38 Record of cleaning shall be maintained in cleaning log book.

Read Also: SOP for Training and Evaluation of the Employee

8. ABBREVIATIONS

8.1 SOP: Standard Operating Procedure

8.2 QA: Quality Assurance

8.3 GMP: Good Manufacturing Practices

8.4 BMR: Batch Manufacturing Record

8.5 BCR: Batch Coating Record

8.6 BPR: Batch Packaging Record

8.7 COA: Certificate of Analysis

9. ANNEXURES

 Nil